Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.

Study Overview
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Brief Summary
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A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.

Detailed Description
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Most existing cardiac rehabilitation programs have little ability to expand participation using traditional delivery models that emphasize supervised, facility-based programs. Futhermore, facility based programs to promote physical activity behavior in patients with coronary artery disease (CAD) are limited in their impact because most patients are unwilling to travel more than 30-40 minutes to participate in a program. CardioFit is an off-site, 26 week web-based physical activity coaching service for people with heart disease. Within the CardioFit program, patients will be assigned to an on-line coach and receive customized exercise programs based on their medical history, personal goals and preferences. A randomized control trial (RCT) is planned to evaluate the effectiveness of the web-based intervention at increasing physical activity levels against usual care in patients with CAD. This study is in the third phase of a three-phase research program to examine interventions to promote physical activity for the secondary prevention of Cardiovascular disease.

Official Title
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Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial

Conditions
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Coronary Artery Disease (CAD)

Intervention / Treatment
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* Behavioral: CardioFit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 to 80 years English Proficiency Internet Access (home or work) Documented CAD (most recent cardiac diagnosis); documented Myocardial Infarction (MI), successful PCI procedure Exclusion Criteria: Patient intends to enroll in structured cardiac rehabilitation Hospitalization for Coronary Artery Bypass (CABG) Hospitalization for diagnostic procedure not associated with previously documented MI Patient coming back to hospital for planned staged PCI within 6 months Cardiac transplantation Presence of, or hospitalization for defibrillator implant Hospitalization for pacemaker implantation Unresolved unstable angina &/or hospitalization for angina (without MI or PCI) Uncontrolled arrhythmias causing symptoms or hemodynamic compromise Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise Other uncontrolled metabolic conditions (e.g. diabetes) Chronic infectious diseases such as mononucleosis, hepatitis, AIDS Acute systematic illness or fever Uncontrolled tachycardia (<120 bpm) Uncompensated congestive heart failure (&/or NYHA Class III, or IV) 3rd degree AV block without pacemaker Active pericarditis or myocarditis Recent embolism Suspected or known AAA aneurysm > 4cm Uncontrolled hypertension (SBP > 200; DBP > 110) Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardio fit<br> | Behavioral: CardioFit<br>* CardioFit is a 26-week tailored web-based physical activity coaching service for individuals with Coronary Artery Disease (CAD). It has been designed to help patients develop personalized exercise programs based on their medical history, personal goals and preferences. Access to Cardio-fit is through a secured website. The cardio-fit website contains physical activity advice and heart health educational information. Each patient is assigned an on-line coach, whose role is to assist in creating safe an effective physical activity program, and to answer any questions that patients may have throughout the program.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: |  | Baseline, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measured at baseline, 6 months, and 12 months via follow-up questionnaire: |  | Baseline, 6 and 12 months | 
| Recurrent cardiac events |  | Baseline, 6 and 12 months | 
| Barriers |  | Baseline, 6 and 12 months | 
| Task Self-efficacy |  | Baseline, 6 and 12 months | 
| Outcome expectations |  | Baseline, 6 and 12 months | 
| Social Support |  | Baseline, 6 and 12 months | 
| Perceived environment |  | Baseline, 6 and 12 months | 
| Heart disease specific quality of life |  | Baseline, 6 and 12 months | 
| Use of secondary prevention medications |  | 6 and 12 months | 
| Pedometer (9days) |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Control Trial, Exercise Intervention, Prevention, Rehabilitation