RESEARCH/Original article
A randomised controlled trial of providing personalised cardiovascular risk information to modify health behaviour
Journal of Telemedicine and Telecare 2014, Vol. 20(3) 147–152 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1357633X14528446 jtt.sagepub.com
Leah L Zullig1, Linda L Sanders2, Ryan J Shaw1,3, Felicia McCant1, Susanne Danus1 and Hayden B Bosworth1,2,3,4
Summary We conducted a feasibility study of a web-based intervention, which provided personalized cardiovascular disease (CVD) risk information, behavioural risk reduction strategies and educational resources. Participants were block-randomized to the 3-month intervention (n ¼ 47) or to usual care (n ¼ 49). Participants in the intervention group were presented with their CVD risk based on the Framingham risk score, and in three subsequent online encounters could select two behavioural/lifestyle modules, giving them an opportunity to complete six modules over the course of the study. Because it was self-guided, participants had differing levels of engagement with intervention materials. Most intervention group participants (77%, n ¼ 36) completed all modules. After 3 months there were no significant differences between the intervention and usual care groups for systolic blood pressure, body-mass index, CVD risk, smoking cessation or medication non-adherence. The study suggests that modest clinical improvements can be achieved by interventions that are entirely web-administered. However, web-based interventions do not replace the need for human interaction to communicate CVD risk and assist with decision-making. Accepted: 11 January 2014
Introduction Cardiovascular disease (CVD) is the leading cause of death in the US.1 Despite widely recommended lifestyle goals and the availability of effective treatment, many people who have developed or are at risk of CVD, fail to meet treatment goals.2,3 A person’s perceived risk of stroke or heart attack is an important factor in their adherence to CVD risk reduction guidelines.4,5 However, people often underestimate their CVD susceptibility.2,6,7 According to the Health Belief Model,8 a person’s beliefs about their disease risk increases the likelihood of behaviour change. Providing tailored CVD risk information may cause patients to initiate and maintain behaviour change, thus improving risk reduction. Furthermore, by providing CVD risk information online, users can access information at their convenience.9 If proven effective, an Internet-delivered intervention could be scaled up for broad dissemination. We have conducted a feasibility study of a web-based intervention, which provided personalized CVD risk information, behavioural risk reduction strategies and educational resources.
Methods Participants were identified through an electronic medical record query. The inclusion criteria were: (1) affiliated
primary care clinic patient for at least one year with one or more visits in the previous year; (2) diagnosed with CVD or a CVD-risk equivalent, e.g. diabetes; (3) having at least one modifiable outcome, e.g. hypertension or actively smoking. Patients were excluded if they: (1) had metastatic cancer, dementia, psychosis or end-stage renal disease; (2) lacked Internet access; (3) received nursing services; (4) were unable to read English; (5) were participating in another CVD study or a household member was a participant; (6) received or were a candidate for a heart transplant; (7) were hospitalized for cardiac-related illnesses in the previous three months; (8) or their arm circumference exceeded 50 cm. Potential participants were sent a recruitment letter approximately two weeks before
1 Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, USA 2 Department of Medicine, Division of General Internal Medicine, Duke University, Durham, USA 3 School of Nursing, Duke University, Durham, USA 4 Department of Psychiatry and Behavioral Sciences, Duke University, Durham, USA
Corresponding author: Dr Hayden Bosworth, Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Suite 600, 411 West Chapel Hill Street, Durham NC 27701, USA. Email: [email protected]
Downloaded from jtt.sagepub.com at Uni of Southern Queensland on March 14, 2015
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Journal of Telemedicine and Telecare 20(3)
a primary care clinic visit. A research staff member contacted them via telephone and arranged to meet in person and explain the study.
Randomization After providing consent, participants were block-randomized to the 3-month intervention or to usual care. Randomization assignments were placed in sealed, consecutively numbered envelopes. The staff involved in the randomization were blinded to the block size.
Study design There was one face-to-face meeting during the study period to obtain consent and provide the initial educational information. CVD risk and treatment adherence outcomes were assessed face-to-face at baseline and after 3-months.10–18 The study was approved by the appropriate ethics committee.
Intervention group At baseline, participants in the intervention group were presented with their CVD risk based on the Framingham risk score.19 All other interactions were conducted electronically. In the first online encounter, participants used a webbased Framingham risk calculator. They adjusted their own risk scores and indicated areas they were willing to modify. For example, participants could indicate their readiness to change one aspect of their CVD risk (e.g. smoking cessation), but could remain tentative about altering another (e.g. exercise). Tailored educational information was provided based on participants’ readiness to change. For example, if participants were ready to make dietary changes, they were given literature about balancing caloric expenditure and using the glycaemic index to identify healthy food choices and control hunger. This educational material was provided electronically in PDF
format and included information about diet (e.g. glycaemic index); physical activity (e.g. moving more) and smoking (e.g. education and no-smoking reminders). Subsequent follow-up encounters were not scheduled. Patients were able to login at their own convenience. However, patients were sent an email message each month to remind them to login to complete the encounter. If a patient failed to login one week after the initial reminder, then a follow-up email message was sent to the patient. The follow-up message informed the patient that they had two weeks to complete the online encounter and that only seven days remained. At each online encounter, participants selected two behavioural/lifestyle modules, giving them an opportunity to complete six modules over the course of the study (Table 1). After selecting a module, the subsequent follow-up encounters (online) were used to reinforce the previous interaction and facilitate maintenance or, if necessary, revise health behaviour goals. The modules provided evidence-based recommendations regarding lifestyle behaviours and participants were advised how to achieve their goals with respect to these behaviours. The intervention components were designed to be culturally sensitive. The behavioural modules covered diet, exercise, smoking, alcohol, patient-provider relationships and medication management (Table 2). All these measures have been used in previous clinical trials and are easy to implement, reliable and sensitive to change.20,21 Each module asked the patient about their current beliefs and health practices. Based on the patient’s responses to a series of questions, there was tailored feedback to reinforce behaviour change. In addition, information on CVD medication management and side effects were provided with each encounter.
Control group Participants in the usual care group received general, printed educational CVD information and additional information at their providers’ discretion. If requested, participants were given intervention materials at the
Table 1. Intervention content. Participants selected two modules each month. Modules Month 1 Medication adherence Diet – heart healthy Physical activity Month 2 Medication adherence Diet – low sodium Risk factor knowledge Month 3 Medication adherence Diet – portion control Smoking cessation
Health behaviours
Goal
Actively trying to improve diet Not exercising
Compliance Maintain healthy eating Develop plan for regular exercise
Actively trying to improve diet Blood pressure, smoking status, cholesterol level
Compliance Maintain healthy eating and reduce salt intake Identify risk factors
Actively trying to improve diet Smoker
Compliance Maintain healthy eating, reduce salt intake, measure intake Stop smoking
Downloaded from jtt.sagepub.com at Uni of Southern Queensland on March 14, 2015
Zullig et al.
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Table 2. Baseline characteristics. Unless otherwise noted, values shown are number (%).
Mean age, years (SD) Race Caucasian African American Other Male Partnered (married or living together) Completed more than 12 years of school Low literacy level (REALM score
A randomised controlled trial of providing personalised cardiovascular risk information to modify health behaviour
Journal of Telemedicine and Telecare 2014, Vol. 20(3) 147–152 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1357633X14528446 jtt.sagepub.com
Leah L Zullig1, Linda L Sanders2, Ryan J Shaw1,3, Felicia McCant1, Susanne Danus1 and Hayden B Bosworth1,2,3,4
Summary We conducted a feasibility study of a web-based intervention, which provided personalized cardiovascular disease (CVD) risk information, behavioural risk reduction strategies and educational resources. Participants were block-randomized to the 3-month intervention (n ¼ 47) or to usual care (n ¼ 49). Participants in the intervention group were presented with their CVD risk based on the Framingham risk score, and in three subsequent online encounters could select two behavioural/lifestyle modules, giving them an opportunity to complete six modules over the course of the study. Because it was self-guided, participants had differing levels of engagement with intervention materials. Most intervention group participants (77%, n ¼ 36) completed all modules. After 3 months there were no significant differences between the intervention and usual care groups for systolic blood pressure, body-mass index, CVD risk, smoking cessation or medication non-adherence. The study suggests that modest clinical improvements can be achieved by interventions that are entirely web-administered. However, web-based interventions do not replace the need for human interaction to communicate CVD risk and assist with decision-making. Accepted: 11 January 2014
Introduction Cardiovascular disease (CVD) is the leading cause of death in the US.1 Despite widely recommended lifestyle goals and the availability of effective treatment, many people who have developed or are at risk of CVD, fail to meet treatment goals.2,3 A person’s perceived risk of stroke or heart attack is an important factor in their adherence to CVD risk reduction guidelines.4,5 However, people often underestimate their CVD susceptibility.2,6,7 According to the Health Belief Model,8 a person’s beliefs about their disease risk increases the likelihood of behaviour change. Providing tailored CVD risk information may cause patients to initiate and maintain behaviour change, thus improving risk reduction. Furthermore, by providing CVD risk information online, users can access information at their convenience.9 If proven effective, an Internet-delivered intervention could be scaled up for broad dissemination. We have conducted a feasibility study of a web-based intervention, which provided personalized CVD risk information, behavioural risk reduction strategies and educational resources.
Methods Participants were identified through an electronic medical record query. The inclusion criteria were: (1) affiliated
primary care clinic patient for at least one year with one or more visits in the previous year; (2) diagnosed with CVD or a CVD-risk equivalent, e.g. diabetes; (3) having at least one modifiable outcome, e.g. hypertension or actively smoking. Patients were excluded if they: (1) had metastatic cancer, dementia, psychosis or end-stage renal disease; (2) lacked Internet access; (3) received nursing services; (4) were unable to read English; (5) were participating in another CVD study or a household member was a participant; (6) received or were a candidate for a heart transplant; (7) were hospitalized for cardiac-related illnesses in the previous three months; (8) or their arm circumference exceeded 50 cm. Potential participants were sent a recruitment letter approximately two weeks before
1 Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, USA 2 Department of Medicine, Division of General Internal Medicine, Duke University, Durham, USA 3 School of Nursing, Duke University, Durham, USA 4 Department of Psychiatry and Behavioral Sciences, Duke University, Durham, USA
Corresponding author: Dr Hayden Bosworth, Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Suite 600, 411 West Chapel Hill Street, Durham NC 27701, USA. Email: [email protected]
Downloaded from jtt.sagepub.com at Uni of Southern Queensland on March 14, 2015
148
Journal of Telemedicine and Telecare 20(3)
a primary care clinic visit. A research staff member contacted them via telephone and arranged to meet in person and explain the study.
Randomization After providing consent, participants were block-randomized to the 3-month intervention or to usual care. Randomization assignments were placed in sealed, consecutively numbered envelopes. The staff involved in the randomization were blinded to the block size.
Study design There was one face-to-face meeting during the study period to obtain consent and provide the initial educational information. CVD risk and treatment adherence outcomes were assessed face-to-face at baseline and after 3-months.10–18 The study was approved by the appropriate ethics committee.
Intervention group At baseline, participants in the intervention group were presented with their CVD risk based on the Framingham risk score.19 All other interactions were conducted electronically. In the first online encounter, participants used a webbased Framingham risk calculator. They adjusted their own risk scores and indicated areas they were willing to modify. For example, participants could indicate their readiness to change one aspect of their CVD risk (e.g. smoking cessation), but could remain tentative about altering another (e.g. exercise). Tailored educational information was provided based on participants’ readiness to change. For example, if participants were ready to make dietary changes, they were given literature about balancing caloric expenditure and using the glycaemic index to identify healthy food choices and control hunger. This educational material was provided electronically in PDF
format and included information about diet (e.g. glycaemic index); physical activity (e.g. moving more) and smoking (e.g. education and no-smoking reminders). Subsequent follow-up encounters were not scheduled. Patients were able to login at their own convenience. However, patients were sent an email message each month to remind them to login to complete the encounter. If a patient failed to login one week after the initial reminder, then a follow-up email message was sent to the patient. The follow-up message informed the patient that they had two weeks to complete the online encounter and that only seven days remained. At each online encounter, participants selected two behavioural/lifestyle modules, giving them an opportunity to complete six modules over the course of the study (Table 1). After selecting a module, the subsequent follow-up encounters (online) were used to reinforce the previous interaction and facilitate maintenance or, if necessary, revise health behaviour goals. The modules provided evidence-based recommendations regarding lifestyle behaviours and participants were advised how to achieve their goals with respect to these behaviours. The intervention components were designed to be culturally sensitive. The behavioural modules covered diet, exercise, smoking, alcohol, patient-provider relationships and medication management (Table 2). All these measures have been used in previous clinical trials and are easy to implement, reliable and sensitive to change.20,21 Each module asked the patient about their current beliefs and health practices. Based on the patient’s responses to a series of questions, there was tailored feedback to reinforce behaviour change. In addition, information on CVD medication management and side effects were provided with each encounter.
Control group Participants in the usual care group received general, printed educational CVD information and additional information at their providers’ discretion. If requested, participants were given intervention materials at the
Table 1. Intervention content. Participants selected two modules each month. Modules Month 1 Medication adherence Diet – heart healthy Physical activity Month 2 Medication adherence Diet – low sodium Risk factor knowledge Month 3 Medication adherence Diet – portion control Smoking cessation
Health behaviours
Goal
Actively trying to improve diet Not exercising
Compliance Maintain healthy eating Develop plan for regular exercise
Actively trying to improve diet Blood pressure, smoking status, cholesterol level
Compliance Maintain healthy eating and reduce salt intake Identify risk factors
Actively trying to improve diet Smoker
Compliance Maintain healthy eating, reduce salt intake, measure intake Stop smoking
Downloaded from jtt.sagepub.com at Uni of Southern Queensland on March 14, 2015
Zullig et al.
149
Table 2. Baseline characteristics. Unless otherwise noted, values shown are number (%).
Mean age, years (SD) Race Caucasian African American Other Male Partnered (married or living together) Completed more than 12 years of school Low literacy level (REALM score
