Psychopharmacol Bull. 2017;47(3):17–25. Original Presentations Key Words: antipsychotic agents, caregivers, day care, medical, demography, emergency service, hospital, FIRST study, hospitalization, internet, outpatients, paliperidone palmitate, psychotic disorders, schizophrenia, suicide

Correlation of Caregiver Burden and Baseline Characteristics of Caregivers and Patients in Their Care with Recent-Onset Psychosis: The FIRST Study By Branislav Mancevski, Jagadish Gogate, Katie Ashcroft, Kristy Tardieu, Ed Kim

Introduction • Caregivers who provide vital support to patients with mental illness nonetheless experience substantial burden,1 especially in the schizophrenia setting2 • The benefits of Web-based education and training programs have been demonstrated for patients and their caregivers in a variety of psychiatric-disorder settings3–6 • Family Intervention in Recent-Onset Schizophrenia Treatment (FIRST) is a novel study that is evaluating the overall effect of interactive, Web-based caregiver psychoeducation and skills training versus usual caregiver support on the number of patient treatment failures and on caregiver burden during a 12-month period. Patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder were included in the study • The aim of this current analysis is to describe the demographic and baseline characteristics of caregivers and patients enrolled in the FIRST study and to evaluate the correlation between caregiver burden, caregiver general health, and severity of patient illness

Presented at the American Psychiatric Association Annual Meeting, May 20–24, 2017, San Diego, CA. Drs. Mancevski, Tardieu, Kim, Janssen Scientific Affairs, LLC, Titusville, NJ; Dr. Gogate, Janssen Research and Development, LLC, Titusville, NJ; Dr. Ashcroft, Healios, Inc, High Bridge, NJ. To whom correspondence should be addressed: Dr. Mancevski is Director, Clinical Development at Janssen Scientific Affairs, LLC, Titusville, NJ, 1125 Trenton Harbourton Road Titusville, New Jersey 08560 USA. Phone: 610.651.6000; Fax: 610.651.6100; E-mail: [email protected]

P sychopharmacol B ull :  Vol. 47 · No. 3  •  17

PB-Mancevski.indd 17

8/4/2017 3:13:07 PM

Jo V Is Y A R

Correlation of Caregiver Burden and Baseline Characteristics

Methods FIRST Study Design • FIRST (NCT02600741) is an open-label, parallel-group, randomized, multicenter, phase-4 study conducted at approximately 30 US sites • Its target enrollment is 300 caregiver-patient pairs • A caregiver is defined as a person who has accepted responsibility for providing the patient with assistance with activities of daily living and with protection from harm. Caregivers can be members of the immediate or extended family, friends, neighbors, or significant others • Key eligibility criteria • Patients Aged 18–35 years with a clinical diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder Receiving ongoing psychiatric treatment (i.e., oral antipsychotics or paliperidone palmitate long-acting therapy) Experienced ⩾1 treatment failure within 6 months prior to screening (defined as psychiatric hospitalization, psychiatric emergency room visit, intensive outpatient treatment/partial hospitalization due to a crisis center visit, mobile crisis unit intervention, arrest/ incarceration, or suicide attempt) • Caregivers Aged ⩾18 years Have verbal interaction with the patient ⩾2 times per week and Web access Willing to participate for the study’s 12-month duration • Details of the FIRST study design are summarized in Figure 1 



18 Mancevski, Gogate, Ashcroft, et al.









Analyses • The current cross-sectional analysis of baseline data is focused on the correlation between baseline caregiver- and patient-reported measures and severity of patient illness • Illness severity was rated by the treating clinician using the Clinical Global Impression of Severity (CGI-S) rating scale where 1 = normal and 7 = extremely ill7 • Patient-reported outcomes • Illness Management and Recovery (IMR) score8: 15-item instrument that measures illness self-management and pursuit of recovery goals in patients with severe mental illness. Higher IMR scores correspond to better patient outcomes P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 18

8/4/2017 3:13:07 PM

Correlation of Caregiver Burden and Baseline Characteristics FIGURE 1

Schematic of the First Study &DUHJLYHU5DQGRPL]DWLRQ 3DWLHQW¶VURXWLQH DQWLSV\FKRWLF WUHDWPHQWDW WLPHRIHQWU\ 3DOLSHULGRQH 3DOPLWDWH 1  6FUHHQLQJ

6WXG\JURXSVWXG\SURYLGHGFDUHJLYHU SV\FKRHGXFDWLRQDQGVNLOOVWUDLQLQJD Q  6WXG\JURXSXVXDOFDUHJLYHUVXSSRUWE Q 

2UDO $QWLSV\FKRWLF 1 

6WXG\JURXSVWXG\SURYLGHGFDUHJLYHU SV\FKRHGXFDWLRQDQGVNLOOVWUDLQLQJD Q  6WXG\JURXSXVXDOFDUHJLYHUVXSSRUWE Q  0RQWK 

0RQWK 

0RQWK 

Notes: aCaregivers will receive up to 16 individualized, study-provided, Web-based psychoeducation and skills training (MyHealios™) sessions over 6 months by a trained clinician in real time. Caregivers will also have access to online training modules for self-review on an as-needed basis. bThis is the caregiver support that (if any) is customarily provided by the study site.

19 • Caregiver-reported outcomes • Involvement Evaluation Questionnaire (IEQ)9: 31-item questionnaire that assesses levels of caregiver burden in caregivers of patients with schizophrenia across four dimensions (tension, supervision, worrying, and urging) on a 5-point Likert response scale over a 4-week recall period. A higher IEQ score corresponds to greater caregiver burden • 12-item Short-Form Health Survey (SF-12).10 Questionnaire with 12 items that assesses the overall mental (Mental Component Summary [MCS]) and physical (Physical Component Summary [PCS]) functioning of an individual, regardless of disease status. Scores range from 0 to 100, with higher scores indicating greater functioning, and were calculated using QualityMetric converted values (norm-based scoring)

Mancevski, Gogate, Ashcroft, et al.

Statistical Methods • Demographic and baseline characteristics were summarized using descriptive statistics • The relationship between caregiver burden and severity of patient illness as well as the relationship between caregiver burden and caregiver overall mental and physical components at baseline were assessed using Pearson correlation coefficient. Furthermore, regression analyses were performed to obtain mean and prediction intervals P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 19

8/4/2017 3:13:08 PM

Correlation of Caregiver Burden and Baseline Characteristics

Results Patient and Caregiver Characteristics at Baseline • The current analysis is based on interim data from 85 patient-caregiver pairs (data cutoff: March 23, 2017) • Baseline patient and caregiver characteristics are shown in Table 1 Correlation Between Caregiver IEQ Total Scores and Patient CGI-S and IMR Scores at Baseline

20 Mancevski, Gogate, Ashcroft, et al.

• Caregivers’ mean baseline IEQ total scores appeared to be higher in patients with higher CGI-S ratings at baseline, indicating greater caregiver burden in patients with more severe illness (Figure 2) • Four dimensions of the IEQ score also exhibited generally similar trends (Figure 3) • There was a significant positive correlation between caregivers’ IEQ total scores and patients’ CGI-S scores at baseline (r = 0.273; P = 0.0151; Figure 2) • Significant positive correlations were also observed between baseline CGI-S scores and the tension and worrying dimensions of the IEQ scale, but not the supervision or urging dimensions (Figure 3) • A significant negative correlation was observed between caregivers’ IEQ total scores and patients’ IMR scores at baseline, suggesting lower caregiver burden associated with higher functional status (r = −0.290; P = 0.0091; Figure 4) • Significant negative correlations were also observed between baseline IMR scores and the tension (r = −0.380; P = 0.0005), ­supervision (r = −0.272; P = 0.0139), and worrying (r = −0.266; P = 0.0146) dimensions of the IEQ scale, but not the urging dimension (r = −0.153; P = 0.1757) Correlation Between Caregiver SF-12 Scores and Patient CGI-S and IMR Scores at Baseline • There was no significant correlation between patients’ CGI-S scores and caregivers’ SF-12 PCS (r = 0.039; P = 0.7295) or MCS (r = −0.106; P = 0.3399) domain scores at baseline • Similarly, no significant correlation was found between patients’ baseline IMR total scores and caregivers’ SF-12 PCS (r = −0.024; P = 0.8259) or MCS (r = 0.165; P = 0.1328) domain scores • These results suggest that caregivers’ mental and physical functioning were not associated with patients’ clinical severity or functional status

P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 20

8/4/2017 3:13:08 PM

Correlation of Caregiver Burden and Baseline Characteristics TABLE 1

Demographic and Baseline Characteristics for Caregivers and Patients

Age, years, mean (SD) Sex, n (%) Female Male Race, n (%) White Black/African American Multiple Other Not reported Ethnicity, n (%) Hispanic or Latino Not Hispanic or Latino Not reported Living status, n (%) At home (with family or friends) At home (alone) Unknown Sheltered living Other Relationship to the patient, n (%) Mother/fathera Spouse/partner Friend Sister/brother Other relative Other Education, n (%) Doctoral degree or professional degree ( JD, MD) Master’s degree 4-year college degree 2-year college degree Some college Vocational training program High school/GED Less than high school Unknown Relationship status, n (%) Married/in long-term relationship Single Divorced Widowed Unknown

CAREGIVERS N = 85

PATIENTS N = 85

52.1 (10.9)

25.6 (5.0)

65 (76.5) 20 (23.5)

21 (24.7) 64 (75.3)

52 (61.2) 28 (32.9) 2 (2.4) 2 (2.4) 1 (1.2)

50 (58.8) 30 (35.3) 1 (1.2) 4 (4.7) –

9 (10.6) 75 (88.2) 1 (1.2)

10 (11.8) 75 (88.2) –

– – – – –

75 (88.2) 6 (7.1) 2 (2.4) 1 (1.2) 1 (1.2)

73 (85.9) 4 (4.7) 3 (3.5) 1 (1.2) 2 (2.4) 2 (2.4)

– – – – – –

1 (1.2) 11 (12.9) 11 (12.9) 8 (9.4) 24 (28.2) 4 (4.7) 18 (21.2) 7 (8.2) 1 (1.2)

– – – – – – – – –

42 (49.4) 20 (23.5) 17 (20.0) 5 (5.9) 1 (1.2)

– – – – –

21 Mancevski, Gogate, Ashcroft, et al.

(Continued)

P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 21

8/4/2017 3:13:08 PM

Correlation of Caregiver Burden and Baseline Characteristics TABLE 1 (Continued)

CAREGIVERS N = 85

CGI-S scores,b mean (SD) Categorical CGI-S scores, n (%) Borderline ill (2) Mildly ill (3) Moderately ill (4) Markedly ill (5) Severely ill (6) Extremely ill (7) IMR total score,c mean (SD) IEQ total score,d mean (SD) SF-12 scores,c,e mean (SD) PCS MCS

22

PATIENTS N = 85

– – – – – – – 29.0 (15.9)

4.1 (1.3) 9 (10.6) 16 (18.8) 29 (34.1) 14 (16.5) 14 (16.5) 1 (1.2) 48.9 (6.9) –

49.8 (11.0) 47.5 (9.5)

– –

Notes: aIncludes stepparents, foster parents, and adoptive parents. bn = 83. cn = 84. dn = 80. eSF-12 scores are QualityMetric converted values (norm-based scoring); there is no total SF-12 score. Abbreviations: GED, general educational development; JD, juris doctor; MD, doctor of medicine; SD, standard deviation.

Mancevski, Gogate, Ashcroft, et al. FIGURE 2

Baseline IEQ Total Scores by Baseline CGI-S Categorical Scores (N = 83)

0HDQ%DVHOLQH,(4 7RWDO6FRUHV

&DUHJLYHU%XUGHQ



U 3 

      

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6&DWHJRULFDO6FRUHVDW%DVHOLQH 3DWLHQW&OLQLFDO6HYHULW\

P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 22

8/4/2017 3:13:08 PM

Correlation of Caregiver Burden and Baseline Characteristics FIGURE 3

0HDQ%DVHOLQH,(4 6XEVFDOH6FRUHV

&DUHJLYHU%XUGHQ

Baseline IEQ Subscale Scores by Baseline CGI-S Categorical Scores (N = 83) 

,(47HQVLRQU 3 



,(46XSHUYLVLRQU 3 

 

,(4:RUU\LQJ U 3  ,(48UJLQJ U 3 

   

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6 Q 

&*,6&DWHJRULFDO6FRUHVDW%DVHOLQH

23

3DWLHQW&OLQLFDO6HYHULW\

Mancevski, Gogate, Ashcroft, et al. FIGURE 4

Mean and Prediction Intervals of Caregiver IEQ Total Score by Patient IMR Total Score 

U  ±3 



,(47RWDO6FRUH

&DUHJLYHU%XUGHQ

       ± ±















,057RWDO6FRUH 3DWLHQW)XQFWLRQDO6WDWXV

P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 23

8/4/2017 3:13:09 PM

Correlation of Caregiver Burden and Baseline Characteristics FIGURE 5

Mean and Prediction Intervals of Caregiver IEQ Total Score by Baseline SF-12 MCS Scores 

U  ±3 



,(47RWDO6FRUH

&DUHJLYHU%XUGHQ

       ± ±





24

















6)0&66FRUH

Mancevski, Gogate, Ashcroft, et al.

&DUHJLYHU)XQFWLRQDO6WDWXV

Correlation Between Caregiver SF-12 Scores and IEQ Total Scores • There was a significant negative correlation between caregivers’ IEQ total scores and SF-12 MCS scores, suggesting that lower caregiver burden is associated with better mental functioning (r = −0.295; P = 0.0079; Figure 5) Limitations • The study’s sample size was limited because study enrollment is ongoing • These data are preliminary • The cross-sectional nature of this analysis cannot assess the causality of patient severity • Data have not been collected on other variables known in the public domain to correlate with care burden (e.g., appraisals about the impact of illness) Discussion • This preliminary analysis described the baseline characteristics of patients and caregivers. It was observed that most patients were young P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 24

8/4/2017 3:13:09 PM

Correlation of Caregiver Burden and Baseline Characteristics

men living at home with their family or friends and that most caregivers were parents of the patients • A greater severity of patient illness was associated with higher caregiver burden, and higher levels of patient functioning were associated with lower caregiver burden • Lower caregiver burden was associated with higher caregiver mental functioning. Caregivers’ mental and physical functioning were not associated with patients’ clinical severity or functional status • Reducing caregiver burden may increase the likelihood that caregivers will remain engaged and supportive of patient recovery (e.g., a patient’s prognosis has been found to be better if the patient receives contact from a caregiver11) • The novel design of the FIRST study allows for evaluation of the role of interactive, Web-based psychoeducation and skills training for caregivers of patients recently diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder D 25

Acknowledgements The authors thank Lian Mao, an employee of Janssen Scientific Affairs, LLC, for his assistance with the statistical analysis. The authors also thank Matthew Grzywacz, PhD, and Julia Burke, PhD, of ApotheCom (Yardley, PA) for their writing and editorial assistance.

Mancevski, Gogate, Ashcroft, et al.

Disclosures B. Mancevski, K. Tardieu, and E. Kim are employees of Janssen Scientific Affairs, LLC, and are Johnson & Johnson stockholders. J. Gogate is an employee of Janssen Research and Development, LLC, and is a Johnson & Johnson stockholder. K. Ashcroft is an employee of MyHealios, Inc. References   1. National Alliance on Mental Illness. https://www.nami.org/Find-Support/Family-Members-andCaregivers/Taking-Care-of-Yourself. Accessed May 15, 2017.   2. Gupta S, et al. BMC Psychiatry. 2015;15:162.   3. Hedman E, et al. Acta Psychiatr Scand. 2013;128:457–467.   4. Kenardy J, et al. Behav Cogn Psychother. 2003;31:279–289.   5. Klein B, et al. J Anxiety Dis. 2010;24:635–644.   6. Blom MM, et al. PLoS ONE. 2015;10:e0116622.   7. Guy W. ECDEU Assessment Manual for Psychopharmacology (Revised). US Dept of Health, Education, and Welfare Publication 76–338. Rockville, MD: National Institute of Mental Health; 1976.   8. Mueser KT, et al. Schizophr Bull. 2006;Suppl 1:S32–S43.   9. van Wijngaarden B, et al. Br J Psychiatry. 2000;177:S21–S27. 10. Ware J Jr, et al. Med Care. 1996;34:220–233. 11. Garety PA, et al. Br J Psychiatry. 2008;192:412–423.

P sychopharmacol B ull :  Vol. 47 · No. 3

PB-Mancevski.indd 25

8/4/2017 3:13:09 PM

Correlation of Caregiver Burden and Baseline Characteristics of Caregivers and Patients in Their Care with Recent-Onset Psychosis: The FIRST Study.

Correlation of Caregiver Burden and Baseline Characteristics of Caregivers and Patients in Their Care with Recent-Onset Psychosis: The FIRST Study. - PDF Download Free
NAN Sizes 0 Downloads 9 Views