FEATURE
Potential Benefits for Caregivers of Stroke Survivors Receiving BTX-A and Exercise for Upper Extremity Spasticity Patricia C. Clark1, PhD, RN, FAAN, FAHA, Dawn M. Aycock1, PhD, RN, ANP-BC, Aimee Reiss2, DPT, Dee Tanner1, MSN, RN, Neeta V. Shenvi3, MS, Kirk A. Easley3, MS & Steven L. Wolf2, PhD, PT, FAPTA 1 Byrdine F. Lewis School of Nursing, Georgia State University, Atlanta, GA, USA 2 Department of Rehabilitation Medicine, School of Medicine, Emory University, Atlanta, GA, USA 3 Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA, USA
Keywords
Abstract
Stroke; family caregiving; rehabilitation. Correspondence Patricia C. Clark, Bydine F. Lewis School of Nursing, Georgia State University, PO Box 4019, Atlanta, GA 30302-4019. E-mail: [email protected] Part of these data were presented – 2011 (February) International Stroke Conference in Los Angeles. Accepted November 09, 2013. doi: 10.1002/rnj.147
Purpose: To explore possible extended benefits to caregivers of stroke survivors receiving a treatment of onabotulinumtoxinA (BTX-A) or saline with a structured exercise program. Design: A comparative, prospective, companion study using a nonrandom sample of 16 caregivers of stroke survivors enrolled in a pilot clinical trial comparing BTX-A or saline and exercise for upper extremity spasticity. Methods: The caregiver measures were depressive symptoms, care demands, family conflict surrounding stroke recovery, and mental and physical health status. Findings: There were no statistically significant differences between caregiver groups. Caregivers of stroke survivors who received BTX-A had a greater change in depressive symptoms that may reflect a clinically important change. Estimates of effect sizes between the groups, controlling for baseline values, indicate a trend for moderate to large effects (last evaluation) for fewer depressive symptoms (d = 0.52) and less caregiver burden (d = 0.77 time, 0.85 difficulty) for caregivers of the BTX-A group. Conclusions and Clinical Relevance: Receiving BTX-A did not alter caregiving demands or depressive symptoms compared to those receiving saline. Further research with larger sample sizes is needed to better understand the interdependence of stroke survivors and caregivers on the health of each.
Introduction Stroke is the most common debilitating illness in the United States. More individuals are surviving strokes than ever before (Towfighi & Saver, 2011) and many are permanently disabled. Because of functional limitations after stroke, stroke survivors often require assistance from informal caregivers, usually family members, for even the simplest tasks of daily living (Bakas, Austin, Jessup, Williams, & Oberst, 2004; Grant, Glandon, Elliot, Giger, & Weaver, 2004). The demands of caregiving are difficult and time consuming, and they may negatively affect the
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caregiver’s well-being. Previous studies provide evidence that caregivers of stroke survivors experience burden and negative health consequences, including emotional and physical stress, and risk for depression (Bakas et al., 2004; Clark et al., 2004; Doan et al., 2012; Draper et al., 2007; Grant et al., 2004). One of the most common residual effects for stroke survivors is spasticity of the affected upper extremity (Dajpratham, Kuptniratsaikul, Kovindha, Kuptniratsaikul, & Dejnuntarat, 2009; E. Lundstr€ om, Terent, & Borg, 2008; Watkins et al., 2002). The prevalence of spasticity in stroke survivors has been reported as 21%–41.6% © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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(Dajpratham et al., 2009; Sommerfeld, Eek, Svensson, Holmqvist, & Von Arbin, 2004; Watkins et al., 2002), and direct costs for people with spasticity are estimated to be four-fold higher than for those without spasticity during the first year post stroke (Lundstr€ om, Smits, Borg, & Terent, 2010). To facilitate recovery and promote independence for stroke survivors, neurotherapeutic rehabilitation strategies to improve upper extremity function are being investigated. There is evidence that onabotulinumtoxinA (BTX-A), a neuromuscular transmission blocker, is beneficial in reducing spasticity (Bensmail, Robertson, Fermanian, & Roby-Brami, 2010; Brashear et al., 2002; Chang et al., 2009). Decreased spasticity may lead to improvements in dressing, hygiene, and reaching activities (Sheean, 2006). Some studies have found that individually tailored BTX-A treatment improved caregiver burden for these tasks (Bhakta, Cozens, Chamberlain, & Bamford, 2000; Doan et al., 2012; Lam et al., 2012). In other studies (Elovic et al., 2008; Lagalla, Danni, Reiter, Ceravolo, & Provinciali, 2000), the benefit of decreased limitations in stroke survivors for caregivers was inferred; however, no data or benefit were provided from caregivers’ perspectives. Thus, while the literature suggests that there is improvement in caregiver burden from BTX-A treatment, it remains unclear whether a reduction in spasticity yields benefits for caregivers. Therefore, this study compared the primary outcome of depressive symptoms and secondary outcomes of caregiving demands, mental and physical health status, and family conflict surrounding stroke recovery in caregivers of stroke survivors with upper extremity spasticity who received BTX-A injection along with exercise sessions for upper extremity rehabilitation (BTX-A group) and caregivers of stroke survivors who received a placebo (saline) and exercise (control group). Details of the stroke survivor intervention and outcomes for the survivors have been reported elsewhere (Wolf et al., 2012). The theoretical framework that guided the study was the strength-vulnerability model adapted for caregiving of stroke survivors (Clark et al., 2004). This theory is based on the family life timeline and the occurrence of a major event in the life of the family. Preexisting factors and situation factors affect caregiver outcomes of these events. One such family event is a stroke, which creates vulnerabilities in the family such as disability resulting from stroke, and family conflict. The stroke survivor’s disability affects the caregiver by increasing demands on the caregiver and increasing family conflict, which may affect the © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
caregiver’s mental health. Thus, an intervention that reduces upper extremity spasticity and improves stroke survivor function may reduce caregiving demands and improve caregiver outcomes. Methods Design and participants The caregiving study used an exploratory, prospective, comparative design. Stroke survivors’ data were collected at baseline (Eval 1) with follow-up at approximately 1 month after BTX-A or saline injection and before exercise therapy (Eval 2), at the completion of exercise therapy (Eval 3) and 1 month after completion of exercise therapy (Eval 4). Both groups received 12–16 exercise sessions over 2 months. Exercises included general movement of the affected extremity, strengthening and repetition exercises, and functional activities relevant to the participant. Caregivers were able to attend the exercise sessions if desired. Caregiver data were collected at the same times as stroke survivor data. At Evals 1, 2 and 4, caregivers completed all study questionnaires. However, to reduce participant burden, only two questionnaires (caregiver demands and family conflict) were administered at Eval 3, which followed completion of the exercise sessions for survivors. Family members of patients enrolled in the survivor intervention study were invited to participate in this companion study. Eligible caregivers were family members or other nonpaid adults (age greater than 18 years) who self-identified and were identified by stroke survivors as providing the most assistance to the survivor. Caregivers had to be able to read and write English and to have no significant cognitive deficits. A total of 25 stroke survivors were enrolled in the main study and 21 of those had a caregiver. Two caregivers declined to participate because they were “too busy” and two caregivers failed to return baseline measures. Thus, a total of 17 caregivers were enrolled in this study. Caregivers agreeing to participate signed a written informed consent approved by our Institutional Review Board. One caregiver who was partnered with a patient in the BTA-X group dropped out after baseline evaluation because of separation from the stroke survivor. Therefore, data are reported here on a final sample of 16 caregivers who completed data at more than one time point; 7 were caregivers caring for stroke survivors in the BTX-A group and 9 were caring for persons
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in the control group. Two caregivers failed to complete instruments for Eval 3, and these missing values were not replaced. Instruments Depressive Symptoms Caregiver depressive symptoms were measured using the well-established Center for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977), a 20-item Likert-type scale whose total scores range from 0 to 60, with higher scores indicating more depressive symptoms. A total score of ≥16 indicates major depressive symptoms. Participants were asked to rate on a Likert-type scale how often a particular symptom was experienced over the past week (Radloff, 1977). If CES-D scores were ≥16, caregivers were contacted and informed that their responses indicated they might benefit from further evaluation for depression. Caregiver mental and physical health were measured using the mental and physical health component scores of the well-established Short Form 36 Health Survey Questionnaire (SF-36v2) (Ware, Kosinski, & Keller, 1994). The SF-36v2 is a 36-item, self-report survey with a score range from 0 to100. Higher scores indicate better overall physical and mental health (Ware et al., 1994). Caregiving Demands Caregiving demands were measured using the Oberst Caregiving Burden Scale (OCBS) (Carey, Oberst, McCubbin, & Hughes, 1991), which assesses the degree of time and difficulty of tasks caregivers often perform. The OCBS is a 15item instrument and individuals are asked to rate the time spent performing typical caregiver tasks as well as the degree of difficulty related to these tasks on a Likert-type 1–5 response scale. Separate scores are computed for the time spent performing tasks and for task difficulty. Total scores for each scale range from 15 to 75. Internal consistency reliability of the scales was adequate in a large sample of caregivers of stroke survivors (Bakas et al., 2004). Family Conflict Surrounding Stroke Recovery Family conflict surrounding stroke recovery was measured using the Family Caregiver Conflict Scale (FCCS) (Clark, Shields, Aycock, & Wolf, 2003). The FCCS is a 15-item, Likert-type scale with response ratings of 1 (not true at all) to 7 (very true). Total scores range from 15 to 105, with higher scores representing greater family conflict (Clark et al., 2003). There is preliminary evidence of the reliability and validity of the FCCS (Clark et al., 2003).
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Family Functioning The broader concept of family functioning was measured using the General Family Functioning (GFF) scale, which is a sub-scale of the McMaster Family Assessment Device (FAD) (Miller, Epstein, Bishop, & Keitner, 1985). The 12-item GFF assesses overall family functioning and interaction. Total scores are an average of the item scores, which range from 1 to 4, and higher scores indicate less effective family functioning. Exit Interview At the study end, a brief exit interview was conducted with each caregiver. An author-developed, semi-structured questionnaire assessed caregivers’ perspectives on the experience and what they felt was important. Also, five items addressed what it was like to help stroke survivors, how stressful it was, and how much caregivers perceived stroke survivors had recovered. Caregivers responded using a scale of 1–10. Caregivers also were asked what was most difficult and best about their experience. Stroke Survivor’s Perception of Hand Function On the Stroke Impact Scale (SISv2) (Duncan et al., 1999) a single item which captures overall recovery from stroke was adapted to assess stroke survivors’ perceptions of overall recovery of hand function. These data were extracted from the companion study (Wolf et al., 2012) database. Score range from 0 to 100 with higher scores representing greater perceived hand function. Data analysis The primary outcome was caregiver depressive symptoms. Secondary outcomes included caregiver mental and physical health, family conflict surrounding stroke recovery, general family functioning, and structured items from the exit interview. Although the scales used were ordinal, the score range was wide and therefore repeated measures analyses using SAS Proc Mixed (version 9) were performed for the caregiver outcome variables (Howard, 2007). The independent variables in each model were the treatment group of the caregiver’s family member, time on study (4 evaluations), and effects of treatment group by time. Analysis of covariance (ANCOVA) was used to adjust for any baseline differences between treatment groups when estimating caregiver outcome at Eval 4. Group differences at Eval 4 were used to estimate the effect size of the intervention with Cohen’s d. Responses © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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to the open-ended questions in the exit interview were content coded by two coders. Exit interview structured responses were compared between the two groups of caregivers using independent t-tests. Results Participants As is typical, the caregivers of stroke survivors in this study (N = 16) were predominantly female (81%) and spouses (38%) or mothers (25%). The majority were African American (81%), high school educated (62%), unemployed or retired (75%) with an average age of 60 (10.9, range: 45– 81) years. Most were married or living with the survivor (63%) with an income ≤$30,000 (63%); many cared for someone else other than the stroke survivors (44%), and most had a major health problem themselves (75%). The most common health problem for caregivers was hypertension (69%). Stroke survivors were mostly male (58.8%) with an average age of 51 (14.7, range: 23–76) years. They were also African American and at the time of the study were 3–24 months post stroke. Caregiver primary and secondary outcome variables Descriptive statistics for caregiver outcomes are in Table 1. Cronbach’s alphas for questionnaires were adequate (.79 to .91). At Eval 1, on average, the total sample had high depressive symptoms with 53% of careTable 1 Baseline descriptive characteristics of major study variables for caregivers of the two treatment groups and the total sample
Variable Depression Mental Health Physical Health Family Conflict Demands – Time Involved Demands – Difficulty General Family Functioning
CG Control (n = 9)
CG BTX-A (n = 7)
Total Sample (N = 16)
13.1 9.8 46.7 9.0 46.3 12.1 25.8 10.2 46.8 9.7
20.7 13.3 41.95 9.2 46.8 12.6 32.1 11.4 44.6 8.0
16.44 11.7 44.6 9.1 46.6 11.9 28.6 10.9 45.8 8.8
25.7 11.1
25.6 11.3
25.6 10.8
1.90 0.5
2.2 0.6
2.0 0.6
Values denote M SD. CG, Caregiver.
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givers scoring ≥16, indicating possible clinical depression. Mental and physical health scores indicated less than optimal health, caregiver burden scores were above the mid-point of the scale, indicating moderate to high burden, family conflict surrounding stroke recovery was higher than reported in a previous study (Clark et al., 2004) and general family functioning scores were above the cut-off of 2.0 (Miller et al., 1985) indicating ineffective family functioning. Caregiver primary and secondary outcomes over time Figure 1 shows the plots of estimated means over time for the primary caregiver outcome, depression (A), and the secondary outcomes of caregiving demands – time involved (B) and difficulty (C), family conflict surrounding stroke recovery (D), and physical and mental health (E and F). Based on the overlap in the confidence intervals (CI), outcomes did not significantly differ between the caregiver groups. However, mean depression declined by 9 points between Eval 1 and Eval 4 in the BTX-A group but increased by 2 points in the control group. Family functioning scores were similar. Estimates of effect sizes for differences between groups at 1 month after exercise Table 2 includes the estimates of the effects of the intervention at the last follow-up, controlling for Eval 1 scores. Adjusted means for the two groups are presented. Although not significant, on average, caregivers of stroke survivors in the BTX-A group had fewer depressive symptoms, spent less time involved in tasks and reported less task difficulty and less family conflict than caregivers in the control group. Effects were similar for caregivers’ mental health with smaller effects for physical health. Estimated effect sizes were moderate to large for all variables except caregiver physical health. Although not statistically significant, stroke survivors in the BTX-A group reported higher perceived recovery of their hand function (M = 50 21.6) than those in the control group (M = 35 23.5), with an estimated moderate effect size (Cohen’s d = .66, p = .210). Exit interview Almost half (43%) of the caregivers indicated that they had attended all or a majority of the exercise sessions. Structured response items are shown in Table 3.
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Figure 1 Longitudinal changes (mean and 95% CI) by treatment group (7 BTX-A caregivers and 9 control caregivers) for Center for Epidemiologic Studies Depression Scale (CES-D), Oberst Burden Scale, Family Caregiving Conflict Scale (FCCS), mental and physical component of the SF-36. A: CES-D; B and C: caregiving demands (time involved and difficulty); D: FCCS; and E and F: the physical and mental component scores of the SF-36.
Cronbach’s alpha coefficient for the five items was .75. There were no significant differences between caregiver groups. In both groups, caregivers were stressed and found it hard to stand by while stroke survivors attempted to use their weaker arm (Table 3). Caregivers varied in their perceptions of the most difficult aspect of the caregiving experience; some identified having to “push the stroke survivor to be more active,” while others said, “watching the stroke survivor deal with the frustration of trying to use his or her arm.” The best aspect of the experience reported was “seeing improvement in arm movement,” “getting out” to interact with others, and that the intervention “provides hope.”
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Discussion Stroke affects not only the survivor, but family members as well. To fully understand stroke recovery, healthcare providers should examine stroke survivors and their families together (Barskova & Wilz, 2007; Visser-Meily et al., 2006). Family members often serve as caregivers providing the most assistance to stroke survivors during recovery. Progress of the patient toward normalcy has been identified by caregivers as making their role less burdensome (White et al., 2007). For example, results from this study suggest that efforts to improve stroke survivors’ upper extremity function may be beneficial for caregivers. © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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Table 2 Adjusted means by treatment group for caregiver outcomes 1 month after stroke survivors completed exercise therapy (Eval 4), controlling for baseline values Adjusted M SE Caregiver Outcomes
CG Control (n = 9)
CG BTX-A (n = 7) Adjusted M SE
Mean Diff SE (p-value)
Mean Square Error (MSE)
Effect Size Cohen’s d*
Depression Demands – Time Involved Demands – Difficulty Family Conflict General Family Function Physical Health Mental Health
16.4 3.8 43.9 2.0 29.7 3.2 32.6 4.2 2.0 0.1 43.9 2.2 41.2 4.4
10.7 4.3 39.4 2.2 21.5 3.7 27.1 4.8 1.8 0.2 45.2 2.5 46.5 5.0
5.7 5.89 (.35) 4.5 3.0 (.15) 8.3 4.9 (.11) 5.6 6.5 (.41) 0.2 0.2 (.41) 1.3 3.4 (.69) 5.4 6.8 (.45)
121.6 34.6 93.6 153.7 0.2 44.2 168.9
0.52 0.77 0.85 0.44 0.45 0.20 0.41
Cohen’s d* Mean difference/Square root of MSE. CG, Caregiver. Table 3 Exit interview responses for both caregiver groups Variable
CG Control
CG BTX-A
p-value
While my family member with stroke has been working to use his/her weaker hand, it has been stressful for me. While my family member with stroke has been working to use his/her weaker hand, it was hard not to help them complete the activities. Since receiving therapy, my family member is able to do more activities to care for him/herself. Since having therapy, my family member is willing to be more involved in social activities. How much would you say your family member’s ability to use his/her hand has improved?
5.00 3.4
4.43 2.7
.73
6.88 3.7
7.43 2.6
.75
7.50 2.9
5.67 2.7
.25
3.75 3.5
4.17 3.2
.82
4.88 1.6
4.43 1.8
.63
All items rated on a 1–10 scale. Values denote M SD.
The BTX-A, by acting to reduce spasticity, may make the stroke survivor’s disability less noticeable, thus potentially fostering confidence to participate in social activities. Caregivers in this sample had high levels of depressive symptoms at baseline. Most stroke survivors were in the chronic phase of recovery and caregivers had relatively high caregiving demands, higher than those reported by Bakas et al. (2004). Caregiver depressive symptoms early in the recovery period negatively affected aspects of stroke survivor quality of life later in the recovery in a previous study by the authors (Klinedinst et al., 2009). Although differences were not significant, from the first evaluation to the last follow-up, the depressive symptom score for the BTX-A group dropped below the cut-off score that indicates possible clinical depression, whereas control group caregivers showed less change and remained closer to the cut-off score. One explanation could be caregivers with high depressive symptoms received treatment from © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
their healthcare providers. However, at each follow-up, we asked caregivers if they had seen their healthcare provider and although some had seen their provider, none were prescribed treatment. Another explanation may be that small gains in physical function may make stroke survivors more independent in daily care or less frustrated with carrying out activities. As a result, the caregiving role may be less stressful, resulting in fewer depressive symptoms. However, more research with larger samples is needed to better elucidate these possible relationships. Although in the stroke survivor study there were no significant treatment effects, the BTX-A group could complete more tasks governing proximal joint motions and they showed improvements in emotions. Even these small changes in the stroke survivor may influence the caregiver. Family conflict surrounding stroke recovery was higher in this sample than in another study by the authors
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Key Practice Points Upper extremity spasticity is common following stroke and survivors often require assistance from caregivers with daily tasks. Caregiving demands are difficult and time consuming, often resulting in poor caregiver health. Efforts to improve stroke survivors’ upper extremity function may be beneficial to reduce caregiver demands and improve caregiver depressive symptoms. A family-centered approach to rehabilitation processes may help caregivers be more effective partners in facilitating recovery of function for stroke survivors.
(Clark et al., 2004). Caregivers who know how much to “push” stroke survivors to perform their therapy in a supportive, motivating way may find limiting their “pushing” so that they do not become controlling difficult to achieve. Potential sources of conflict were noted in the exit interview. For example, some said. “I’m constantly pushing him. We fight about it but I continue to push him” or “I raised hell when she wouldn’t do what she was supposed to do.” Making sure caregivers are clear about the expectations for stroke survivors performing therapy activities at home may help in reducing conflict. One caregiver pointed out that by attending the training sessions, “I know what he can and cannot do so I can tell him what he needs to be doing at home.” Caregivers are invested in their family member getting better. Teaching family members how to provide positive support, as has been done in other chronic illnesses where treatment adherence is important (Clark & Dunbar, 2003; Dunbar et al., 2005), may help reduce conflict and foster adherence to recommended therapy, resulting in more positive outcomes. Study limitations and strengths A limitation of this study is the small sample size. Given that the study lacked adequate power for detecting differences between groups, estimated effect sizes should be interpreted with caution. Some have suggested that little emphasis be placed on these estimations (Kraemer, Mintz, Noda, Tinklenberg, & Yesavage, 2006). Also, stroke survivors were experiencing upper extremity spasticity, which is not experienced by all stroke survivors, limiting generalizability; however, it is one of the common debilitating sequela of stroke. This study has several strengths. One strength was that the sample was predominantly African Americans, who
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are often not well represented in studies of caregivers of stroke (Hartke & King, 2003; King, Hartke, & Denby, 2007; Lutz, Chumbler, Lyles, Hoffman, & Kobb, 2009; Pierce, Thompson, Govoni, & Steiner, 2012), but are disproportionally affected by stroke. Additional strengths were the use of well-established questionnaires, the rigorous selection criteria for stroke participants in the companion study, and the prospective design. Clinical implications Nurses can help caregivers by guiding them in how to support stroke survivors’ participation in exercise therapy, while recognizing their limits in function. Clarifying the need for repetitive exercises and dealing with their feelings of watching a loved one struggle with performing exercises may help caregivers provide more effective support. Nurses can also help caregivers address their disappointment when stroke survivors do not make anticipated improvements with therapy. The proportion of caregivers with high depressive symptoms in this study also indicates the importance of addressing not only the stroke survivor’s but also the caregiver’s needs. Rehabilitation nurses should administer depression screening instruments to caregivers and make appropriate referrals. Conclusions Recovery from stroke is challenging, especially when spasticity affects upper extremity function and results in decreased ability to perform tasks of daily living. In this study, caregivers of the BTX-A group experienced fewer depressive symptoms, and this may enable them to facilitate stroke survivors’ recovery. More research is needed to determine whether interventions that improve stroke survivors’ upper extremity function also provide benefits for caregivers. Future interventions using a family–centered approach to rehabilitation may help caregivers be more effective partners in facilitating recovery of function for stroke survivors, with better outcomes for both stroke survivors and their caregivers. Acknowledgments This work was supported by an unrestricted education grant from Allergan, Inc. award to Dr. P. Clark and in part by a grant ITT-000121 from Allergan, Inc. awarded to Drs. Steven L. Wolf and S. Bryon Milton for stroke survivors. © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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studies to guide power calculations for study proposals. Archives of General Psychiatry, 63, 484–489. Lagalla, G., Danni, M., Reiter, F., Ceravolo, M.G., & Provinciali, L. (2000). Post-stroke spasticity management with repeated botulinum toxin injections in the upper limb. American Journal of Physical Medicine & Rehabilitations, 79, 377–384. Lam, K., Lau, K., So, K., Tam, C., Wu, Y., Cheung, G., et al. (2012). Can botulinum toxin decrease carer burden in long term care residents with upper limb spasticity? A randomized controlled study. Journal of the American Medical Directors Association, 13(5), 477–484. Lundstr€ om, E., Smits, A., Borg, J., & Terent, A. (2010). Fourfold increase in direct costs of stroke survivors with spasticity compared with stroke survivors without spasticity: the first year after the event. Stroke; A Journal Of Cerebral Circulation, 41, 319–324. Lundstr€ om, E., Terent, A., & Borg, J. (2008). Prevalence of disabling spasticity 1 year after first-ever stroke. European Journal of Neurology: The Official Journal of the European Federation of Neurological Societies, 15, 533–539. Lutz, B.J., Chumbler, N.R., Lyles, T., Hoffman, N., & Kobb, R. (2009). Testing a home-telehealth programme for US veterans recovering from stroke and their family caregivers. Disability and Rehabilitation, 31, 402–409. Miller, I.W., Epstein, N.B., Bishop, D.S., & Keitner, G.I. (1985). The McMaster family assessment device: reliability and validity. Journal of Marital and Family Therapy, 11, 345–356. Pierce, L.L., Thompson, T.L., Govoni, A.L., & Steiner, V. (2012). Caregivers’ incongruence: emotional strain in caring for persons with stroke. Rehabilitation Nursing, 37, 258–266. Radloff, L.S. (1977). The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385–401.
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Potential Benefits for Caregivers of Stroke Survivors Receiving BTX-A and Exercise for Upper Extremity Spasticity Patricia C. Clark1, PhD, RN, FAAN, FAHA, Dawn M. Aycock1, PhD, RN, ANP-BC, Aimee Reiss2, DPT, Dee Tanner1, MSN, RN, Neeta V. Shenvi3, MS, Kirk A. Easley3, MS & Steven L. Wolf2, PhD, PT, FAPTA 1 Byrdine F. Lewis School of Nursing, Georgia State University, Atlanta, GA, USA 2 Department of Rehabilitation Medicine, School of Medicine, Emory University, Atlanta, GA, USA 3 Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA, USA
Keywords
Abstract
Stroke; family caregiving; rehabilitation. Correspondence Patricia C. Clark, Bydine F. Lewis School of Nursing, Georgia State University, PO Box 4019, Atlanta, GA 30302-4019. E-mail: [email protected] Part of these data were presented – 2011 (February) International Stroke Conference in Los Angeles. Accepted November 09, 2013. doi: 10.1002/rnj.147
Purpose: To explore possible extended benefits to caregivers of stroke survivors receiving a treatment of onabotulinumtoxinA (BTX-A) or saline with a structured exercise program. Design: A comparative, prospective, companion study using a nonrandom sample of 16 caregivers of stroke survivors enrolled in a pilot clinical trial comparing BTX-A or saline and exercise for upper extremity spasticity. Methods: The caregiver measures were depressive symptoms, care demands, family conflict surrounding stroke recovery, and mental and physical health status. Findings: There were no statistically significant differences between caregiver groups. Caregivers of stroke survivors who received BTX-A had a greater change in depressive symptoms that may reflect a clinically important change. Estimates of effect sizes between the groups, controlling for baseline values, indicate a trend for moderate to large effects (last evaluation) for fewer depressive symptoms (d = 0.52) and less caregiver burden (d = 0.77 time, 0.85 difficulty) for caregivers of the BTX-A group. Conclusions and Clinical Relevance: Receiving BTX-A did not alter caregiving demands or depressive symptoms compared to those receiving saline. Further research with larger sample sizes is needed to better understand the interdependence of stroke survivors and caregivers on the health of each.
Introduction Stroke is the most common debilitating illness in the United States. More individuals are surviving strokes than ever before (Towfighi & Saver, 2011) and many are permanently disabled. Because of functional limitations after stroke, stroke survivors often require assistance from informal caregivers, usually family members, for even the simplest tasks of daily living (Bakas, Austin, Jessup, Williams, & Oberst, 2004; Grant, Glandon, Elliot, Giger, & Weaver, 2004). The demands of caregiving are difficult and time consuming, and they may negatively affect the
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caregiver’s well-being. Previous studies provide evidence that caregivers of stroke survivors experience burden and negative health consequences, including emotional and physical stress, and risk for depression (Bakas et al., 2004; Clark et al., 2004; Doan et al., 2012; Draper et al., 2007; Grant et al., 2004). One of the most common residual effects for stroke survivors is spasticity of the affected upper extremity (Dajpratham, Kuptniratsaikul, Kovindha, Kuptniratsaikul, & Dejnuntarat, 2009; E. Lundstr€ om, Terent, & Borg, 2008; Watkins et al., 2002). The prevalence of spasticity in stroke survivors has been reported as 21%–41.6% © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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(Dajpratham et al., 2009; Sommerfeld, Eek, Svensson, Holmqvist, & Von Arbin, 2004; Watkins et al., 2002), and direct costs for people with spasticity are estimated to be four-fold higher than for those without spasticity during the first year post stroke (Lundstr€ om, Smits, Borg, & Terent, 2010). To facilitate recovery and promote independence for stroke survivors, neurotherapeutic rehabilitation strategies to improve upper extremity function are being investigated. There is evidence that onabotulinumtoxinA (BTX-A), a neuromuscular transmission blocker, is beneficial in reducing spasticity (Bensmail, Robertson, Fermanian, & Roby-Brami, 2010; Brashear et al., 2002; Chang et al., 2009). Decreased spasticity may lead to improvements in dressing, hygiene, and reaching activities (Sheean, 2006). Some studies have found that individually tailored BTX-A treatment improved caregiver burden for these tasks (Bhakta, Cozens, Chamberlain, & Bamford, 2000; Doan et al., 2012; Lam et al., 2012). In other studies (Elovic et al., 2008; Lagalla, Danni, Reiter, Ceravolo, & Provinciali, 2000), the benefit of decreased limitations in stroke survivors for caregivers was inferred; however, no data or benefit were provided from caregivers’ perspectives. Thus, while the literature suggests that there is improvement in caregiver burden from BTX-A treatment, it remains unclear whether a reduction in spasticity yields benefits for caregivers. Therefore, this study compared the primary outcome of depressive symptoms and secondary outcomes of caregiving demands, mental and physical health status, and family conflict surrounding stroke recovery in caregivers of stroke survivors with upper extremity spasticity who received BTX-A injection along with exercise sessions for upper extremity rehabilitation (BTX-A group) and caregivers of stroke survivors who received a placebo (saline) and exercise (control group). Details of the stroke survivor intervention and outcomes for the survivors have been reported elsewhere (Wolf et al., 2012). The theoretical framework that guided the study was the strength-vulnerability model adapted for caregiving of stroke survivors (Clark et al., 2004). This theory is based on the family life timeline and the occurrence of a major event in the life of the family. Preexisting factors and situation factors affect caregiver outcomes of these events. One such family event is a stroke, which creates vulnerabilities in the family such as disability resulting from stroke, and family conflict. The stroke survivor’s disability affects the caregiver by increasing demands on the caregiver and increasing family conflict, which may affect the © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
caregiver’s mental health. Thus, an intervention that reduces upper extremity spasticity and improves stroke survivor function may reduce caregiving demands and improve caregiver outcomes. Methods Design and participants The caregiving study used an exploratory, prospective, comparative design. Stroke survivors’ data were collected at baseline (Eval 1) with follow-up at approximately 1 month after BTX-A or saline injection and before exercise therapy (Eval 2), at the completion of exercise therapy (Eval 3) and 1 month after completion of exercise therapy (Eval 4). Both groups received 12–16 exercise sessions over 2 months. Exercises included general movement of the affected extremity, strengthening and repetition exercises, and functional activities relevant to the participant. Caregivers were able to attend the exercise sessions if desired. Caregiver data were collected at the same times as stroke survivor data. At Evals 1, 2 and 4, caregivers completed all study questionnaires. However, to reduce participant burden, only two questionnaires (caregiver demands and family conflict) were administered at Eval 3, which followed completion of the exercise sessions for survivors. Family members of patients enrolled in the survivor intervention study were invited to participate in this companion study. Eligible caregivers were family members or other nonpaid adults (age greater than 18 years) who self-identified and were identified by stroke survivors as providing the most assistance to the survivor. Caregivers had to be able to read and write English and to have no significant cognitive deficits. A total of 25 stroke survivors were enrolled in the main study and 21 of those had a caregiver. Two caregivers declined to participate because they were “too busy” and two caregivers failed to return baseline measures. Thus, a total of 17 caregivers were enrolled in this study. Caregivers agreeing to participate signed a written informed consent approved by our Institutional Review Board. One caregiver who was partnered with a patient in the BTA-X group dropped out after baseline evaluation because of separation from the stroke survivor. Therefore, data are reported here on a final sample of 16 caregivers who completed data at more than one time point; 7 were caregivers caring for stroke survivors in the BTX-A group and 9 were caring for persons
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in the control group. Two caregivers failed to complete instruments for Eval 3, and these missing values were not replaced. Instruments Depressive Symptoms Caregiver depressive symptoms were measured using the well-established Center for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977), a 20-item Likert-type scale whose total scores range from 0 to 60, with higher scores indicating more depressive symptoms. A total score of ≥16 indicates major depressive symptoms. Participants were asked to rate on a Likert-type scale how often a particular symptom was experienced over the past week (Radloff, 1977). If CES-D scores were ≥16, caregivers were contacted and informed that their responses indicated they might benefit from further evaluation for depression. Caregiver mental and physical health were measured using the mental and physical health component scores of the well-established Short Form 36 Health Survey Questionnaire (SF-36v2) (Ware, Kosinski, & Keller, 1994). The SF-36v2 is a 36-item, self-report survey with a score range from 0 to100. Higher scores indicate better overall physical and mental health (Ware et al., 1994). Caregiving Demands Caregiving demands were measured using the Oberst Caregiving Burden Scale (OCBS) (Carey, Oberst, McCubbin, & Hughes, 1991), which assesses the degree of time and difficulty of tasks caregivers often perform. The OCBS is a 15item instrument and individuals are asked to rate the time spent performing typical caregiver tasks as well as the degree of difficulty related to these tasks on a Likert-type 1–5 response scale. Separate scores are computed for the time spent performing tasks and for task difficulty. Total scores for each scale range from 15 to 75. Internal consistency reliability of the scales was adequate in a large sample of caregivers of stroke survivors (Bakas et al., 2004). Family Conflict Surrounding Stroke Recovery Family conflict surrounding stroke recovery was measured using the Family Caregiver Conflict Scale (FCCS) (Clark, Shields, Aycock, & Wolf, 2003). The FCCS is a 15-item, Likert-type scale with response ratings of 1 (not true at all) to 7 (very true). Total scores range from 15 to 105, with higher scores representing greater family conflict (Clark et al., 2003). There is preliminary evidence of the reliability and validity of the FCCS (Clark et al., 2003).
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Family Functioning The broader concept of family functioning was measured using the General Family Functioning (GFF) scale, which is a sub-scale of the McMaster Family Assessment Device (FAD) (Miller, Epstein, Bishop, & Keitner, 1985). The 12-item GFF assesses overall family functioning and interaction. Total scores are an average of the item scores, which range from 1 to 4, and higher scores indicate less effective family functioning. Exit Interview At the study end, a brief exit interview was conducted with each caregiver. An author-developed, semi-structured questionnaire assessed caregivers’ perspectives on the experience and what they felt was important. Also, five items addressed what it was like to help stroke survivors, how stressful it was, and how much caregivers perceived stroke survivors had recovered. Caregivers responded using a scale of 1–10. Caregivers also were asked what was most difficult and best about their experience. Stroke Survivor’s Perception of Hand Function On the Stroke Impact Scale (SISv2) (Duncan et al., 1999) a single item which captures overall recovery from stroke was adapted to assess stroke survivors’ perceptions of overall recovery of hand function. These data were extracted from the companion study (Wolf et al., 2012) database. Score range from 0 to 100 with higher scores representing greater perceived hand function. Data analysis The primary outcome was caregiver depressive symptoms. Secondary outcomes included caregiver mental and physical health, family conflict surrounding stroke recovery, general family functioning, and structured items from the exit interview. Although the scales used were ordinal, the score range was wide and therefore repeated measures analyses using SAS Proc Mixed (version 9) were performed for the caregiver outcome variables (Howard, 2007). The independent variables in each model were the treatment group of the caregiver’s family member, time on study (4 evaluations), and effects of treatment group by time. Analysis of covariance (ANCOVA) was used to adjust for any baseline differences between treatment groups when estimating caregiver outcome at Eval 4. Group differences at Eval 4 were used to estimate the effect size of the intervention with Cohen’s d. Responses © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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to the open-ended questions in the exit interview were content coded by two coders. Exit interview structured responses were compared between the two groups of caregivers using independent t-tests. Results Participants As is typical, the caregivers of stroke survivors in this study (N = 16) were predominantly female (81%) and spouses (38%) or mothers (25%). The majority were African American (81%), high school educated (62%), unemployed or retired (75%) with an average age of 60 (10.9, range: 45– 81) years. Most were married or living with the survivor (63%) with an income ≤$30,000 (63%); many cared for someone else other than the stroke survivors (44%), and most had a major health problem themselves (75%). The most common health problem for caregivers was hypertension (69%). Stroke survivors were mostly male (58.8%) with an average age of 51 (14.7, range: 23–76) years. They were also African American and at the time of the study were 3–24 months post stroke. Caregiver primary and secondary outcome variables Descriptive statistics for caregiver outcomes are in Table 1. Cronbach’s alphas for questionnaires were adequate (.79 to .91). At Eval 1, on average, the total sample had high depressive symptoms with 53% of careTable 1 Baseline descriptive characteristics of major study variables for caregivers of the two treatment groups and the total sample
Variable Depression Mental Health Physical Health Family Conflict Demands – Time Involved Demands – Difficulty General Family Functioning
CG Control (n = 9)
CG BTX-A (n = 7)
Total Sample (N = 16)
13.1 9.8 46.7 9.0 46.3 12.1 25.8 10.2 46.8 9.7
20.7 13.3 41.95 9.2 46.8 12.6 32.1 11.4 44.6 8.0
16.44 11.7 44.6 9.1 46.6 11.9 28.6 10.9 45.8 8.8
25.7 11.1
25.6 11.3
25.6 10.8
1.90 0.5
2.2 0.6
2.0 0.6
Values denote M SD. CG, Caregiver.
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givers scoring ≥16, indicating possible clinical depression. Mental and physical health scores indicated less than optimal health, caregiver burden scores were above the mid-point of the scale, indicating moderate to high burden, family conflict surrounding stroke recovery was higher than reported in a previous study (Clark et al., 2004) and general family functioning scores were above the cut-off of 2.0 (Miller et al., 1985) indicating ineffective family functioning. Caregiver primary and secondary outcomes over time Figure 1 shows the plots of estimated means over time for the primary caregiver outcome, depression (A), and the secondary outcomes of caregiving demands – time involved (B) and difficulty (C), family conflict surrounding stroke recovery (D), and physical and mental health (E and F). Based on the overlap in the confidence intervals (CI), outcomes did not significantly differ between the caregiver groups. However, mean depression declined by 9 points between Eval 1 and Eval 4 in the BTX-A group but increased by 2 points in the control group. Family functioning scores were similar. Estimates of effect sizes for differences between groups at 1 month after exercise Table 2 includes the estimates of the effects of the intervention at the last follow-up, controlling for Eval 1 scores. Adjusted means for the two groups are presented. Although not significant, on average, caregivers of stroke survivors in the BTX-A group had fewer depressive symptoms, spent less time involved in tasks and reported less task difficulty and less family conflict than caregivers in the control group. Effects were similar for caregivers’ mental health with smaller effects for physical health. Estimated effect sizes were moderate to large for all variables except caregiver physical health. Although not statistically significant, stroke survivors in the BTX-A group reported higher perceived recovery of their hand function (M = 50 21.6) than those in the control group (M = 35 23.5), with an estimated moderate effect size (Cohen’s d = .66, p = .210). Exit interview Almost half (43%) of the caregivers indicated that they had attended all or a majority of the exercise sessions. Structured response items are shown in Table 3.
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Figure 1 Longitudinal changes (mean and 95% CI) by treatment group (7 BTX-A caregivers and 9 control caregivers) for Center for Epidemiologic Studies Depression Scale (CES-D), Oberst Burden Scale, Family Caregiving Conflict Scale (FCCS), mental and physical component of the SF-36. A: CES-D; B and C: caregiving demands (time involved and difficulty); D: FCCS; and E and F: the physical and mental component scores of the SF-36.
Cronbach’s alpha coefficient for the five items was .75. There were no significant differences between caregiver groups. In both groups, caregivers were stressed and found it hard to stand by while stroke survivors attempted to use their weaker arm (Table 3). Caregivers varied in their perceptions of the most difficult aspect of the caregiving experience; some identified having to “push the stroke survivor to be more active,” while others said, “watching the stroke survivor deal with the frustration of trying to use his or her arm.” The best aspect of the experience reported was “seeing improvement in arm movement,” “getting out” to interact with others, and that the intervention “provides hope.”
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Discussion Stroke affects not only the survivor, but family members as well. To fully understand stroke recovery, healthcare providers should examine stroke survivors and their families together (Barskova & Wilz, 2007; Visser-Meily et al., 2006). Family members often serve as caregivers providing the most assistance to stroke survivors during recovery. Progress of the patient toward normalcy has been identified by caregivers as making their role less burdensome (White et al., 2007). For example, results from this study suggest that efforts to improve stroke survivors’ upper extremity function may be beneficial for caregivers. © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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Table 2 Adjusted means by treatment group for caregiver outcomes 1 month after stroke survivors completed exercise therapy (Eval 4), controlling for baseline values Adjusted M SE Caregiver Outcomes
CG Control (n = 9)
CG BTX-A (n = 7) Adjusted M SE
Mean Diff SE (p-value)
Mean Square Error (MSE)
Effect Size Cohen’s d*
Depression Demands – Time Involved Demands – Difficulty Family Conflict General Family Function Physical Health Mental Health
16.4 3.8 43.9 2.0 29.7 3.2 32.6 4.2 2.0 0.1 43.9 2.2 41.2 4.4
10.7 4.3 39.4 2.2 21.5 3.7 27.1 4.8 1.8 0.2 45.2 2.5 46.5 5.0
5.7 5.89 (.35) 4.5 3.0 (.15) 8.3 4.9 (.11) 5.6 6.5 (.41) 0.2 0.2 (.41) 1.3 3.4 (.69) 5.4 6.8 (.45)
121.6 34.6 93.6 153.7 0.2 44.2 168.9
0.52 0.77 0.85 0.44 0.45 0.20 0.41
Cohen’s d* Mean difference/Square root of MSE. CG, Caregiver. Table 3 Exit interview responses for both caregiver groups Variable
CG Control
CG BTX-A
p-value
While my family member with stroke has been working to use his/her weaker hand, it has been stressful for me. While my family member with stroke has been working to use his/her weaker hand, it was hard not to help them complete the activities. Since receiving therapy, my family member is able to do more activities to care for him/herself. Since having therapy, my family member is willing to be more involved in social activities. How much would you say your family member’s ability to use his/her hand has improved?
5.00 3.4
4.43 2.7
.73
6.88 3.7
7.43 2.6
.75
7.50 2.9
5.67 2.7
.25
3.75 3.5
4.17 3.2
.82
4.88 1.6
4.43 1.8
.63
All items rated on a 1–10 scale. Values denote M SD.
The BTX-A, by acting to reduce spasticity, may make the stroke survivor’s disability less noticeable, thus potentially fostering confidence to participate in social activities. Caregivers in this sample had high levels of depressive symptoms at baseline. Most stroke survivors were in the chronic phase of recovery and caregivers had relatively high caregiving demands, higher than those reported by Bakas et al. (2004). Caregiver depressive symptoms early in the recovery period negatively affected aspects of stroke survivor quality of life later in the recovery in a previous study by the authors (Klinedinst et al., 2009). Although differences were not significant, from the first evaluation to the last follow-up, the depressive symptom score for the BTX-A group dropped below the cut-off score that indicates possible clinical depression, whereas control group caregivers showed less change and remained closer to the cut-off score. One explanation could be caregivers with high depressive symptoms received treatment from © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
their healthcare providers. However, at each follow-up, we asked caregivers if they had seen their healthcare provider and although some had seen their provider, none were prescribed treatment. Another explanation may be that small gains in physical function may make stroke survivors more independent in daily care or less frustrated with carrying out activities. As a result, the caregiving role may be less stressful, resulting in fewer depressive symptoms. However, more research with larger samples is needed to better elucidate these possible relationships. Although in the stroke survivor study there were no significant treatment effects, the BTX-A group could complete more tasks governing proximal joint motions and they showed improvements in emotions. Even these small changes in the stroke survivor may influence the caregiver. Family conflict surrounding stroke recovery was higher in this sample than in another study by the authors
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Key Practice Points Upper extremity spasticity is common following stroke and survivors often require assistance from caregivers with daily tasks. Caregiving demands are difficult and time consuming, often resulting in poor caregiver health. Efforts to improve stroke survivors’ upper extremity function may be beneficial to reduce caregiver demands and improve caregiver depressive symptoms. A family-centered approach to rehabilitation processes may help caregivers be more effective partners in facilitating recovery of function for stroke survivors.
(Clark et al., 2004). Caregivers who know how much to “push” stroke survivors to perform their therapy in a supportive, motivating way may find limiting their “pushing” so that they do not become controlling difficult to achieve. Potential sources of conflict were noted in the exit interview. For example, some said. “I’m constantly pushing him. We fight about it but I continue to push him” or “I raised hell when she wouldn’t do what she was supposed to do.” Making sure caregivers are clear about the expectations for stroke survivors performing therapy activities at home may help in reducing conflict. One caregiver pointed out that by attending the training sessions, “I know what he can and cannot do so I can tell him what he needs to be doing at home.” Caregivers are invested in their family member getting better. Teaching family members how to provide positive support, as has been done in other chronic illnesses where treatment adherence is important (Clark & Dunbar, 2003; Dunbar et al., 2005), may help reduce conflict and foster adherence to recommended therapy, resulting in more positive outcomes. Study limitations and strengths A limitation of this study is the small sample size. Given that the study lacked adequate power for detecting differences between groups, estimated effect sizes should be interpreted with caution. Some have suggested that little emphasis be placed on these estimations (Kraemer, Mintz, Noda, Tinklenberg, & Yesavage, 2006). Also, stroke survivors were experiencing upper extremity spasticity, which is not experienced by all stroke survivors, limiting generalizability; however, it is one of the common debilitating sequela of stroke. This study has several strengths. One strength was that the sample was predominantly African Americans, who
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are often not well represented in studies of caregivers of stroke (Hartke & King, 2003; King, Hartke, & Denby, 2007; Lutz, Chumbler, Lyles, Hoffman, & Kobb, 2009; Pierce, Thompson, Govoni, & Steiner, 2012), but are disproportionally affected by stroke. Additional strengths were the use of well-established questionnaires, the rigorous selection criteria for stroke participants in the companion study, and the prospective design. Clinical implications Nurses can help caregivers by guiding them in how to support stroke survivors’ participation in exercise therapy, while recognizing their limits in function. Clarifying the need for repetitive exercises and dealing with their feelings of watching a loved one struggle with performing exercises may help caregivers provide more effective support. Nurses can also help caregivers address their disappointment when stroke survivors do not make anticipated improvements with therapy. The proportion of caregivers with high depressive symptoms in this study also indicates the importance of addressing not only the stroke survivor’s but also the caregiver’s needs. Rehabilitation nurses should administer depression screening instruments to caregivers and make appropriate referrals. Conclusions Recovery from stroke is challenging, especially when spasticity affects upper extremity function and results in decreased ability to perform tasks of daily living. In this study, caregivers of the BTX-A group experienced fewer depressive symptoms, and this may enable them to facilitate stroke survivors’ recovery. More research is needed to determine whether interventions that improve stroke survivors’ upper extremity function also provide benefits for caregivers. Future interventions using a family–centered approach to rehabilitation may help caregivers be more effective partners in facilitating recovery of function for stroke survivors, with better outcomes for both stroke survivors and their caregivers. Acknowledgments This work was supported by an unrestricted education grant from Allergan, Inc. award to Dr. P. Clark and in part by a grant ITT-000121 from Allergan, Inc. awarded to Drs. Steven L. Wolf and S. Bryon Milton for stroke survivors. © 2014 Association of Rehabilitation Nurses Rehabilitation Nursing 2015, 40, 188–196
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