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

Sponsor

Ottawa Heart Institute Research Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT00265525

Collaborator

Heart and Stroke Foundation of Ontario (Other)

223

Enrollment

Locations

Arms

Duration (Months)

111.5

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease (CAD)	Behavioral: CardioFit	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

223 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardio fit	Behavioral: CardioFit 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.
No Intervention: Usual Care

Arm

Intervention/Treatment

Experimental: Cardio fit

Behavioral: CardioFit

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.

No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: [Baseline, 6 and 12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Centre	London	Ontario	Canada	N6A 5W9
2	Unversity of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7

Sponsors and Collaborators

Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator: Robert Reid, PhD, University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Study Chair: Andrew Pipe, C.M, MD, University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Study Chair: Louise Morrin, MBA, B.Sc., University of Ottawa Heart Institute, Prevention and Rehabilitation Centre