Trial of a Cardiac Rehabilitation Program Delivered Remotely Through the Internet

Cardiovascular Disease Clinical Trial

— vCRP  

Official title:

Randomized Trial of a Cardiac Rehabilitation Program Delivered Remotely Through the Internet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683813
• Other study ID #: 38390
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: May 18, 2015
• Start date: November 2008
• Est. completion date: November 2012

Study information

• Verified date: May 2015
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Simon Fraser UniversityCanada: Providence Health CareCanada: Vancouver Coastal Health AuthorityCanada: Northern Health Authority
• Study type: Interventional

Clinical Trial Summary

Cardiac rehabilitation programs (CRP) are a proven treatment for those with ischemic heart disease (IHD). These programs have been demonstrated to improve adherence to regular physical activity, a healthy diet and smoking cessation, as well as modify risk factors for IHD such as hypercholesterolemia, hypertension, obesity and type 2 diabetes. In addition, CRP are cost effective and can result in a 25% reduction in reoccurrence of mortality. Despite the known benefits of CRP, as little as 10% to 25% of eligible patients attend these programs. One of the main barriers to attendance is proximity to a CRP, as the majority of these programs are limited to hospitals in large urban areas. However, cardiovascular diseases do not discriminate by geography, resulting in a geographic inequity of care for patients living in rural, remote and smaller urban/sub-urban centres. Currently there are no CRP specifically designed for patients in rural and remote areas. The use of the Internet may present itself as a viable alternative. We have recently completed a pilot study of a virtual CRP (vCRP) that demonstrated significant improvements in exercise capacity and risk factors. This investigation will study the vCRP in a group of IHD patients who do not have access to hospital-based CRP.

Hypotheses A. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity compared to usual care, in patients with diagnosed IHD.

B. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity after one year compared to usual care, in patients with diagnosed IHD.

Study Population Men and women over 18 years will be identified from consecutive in-patients of the British Columbia Provincial Heart Centre at St. Paul's Hospital in Vancouver who reside in either the Northern Interior or Coast Garibaldi health areas. Patients will be eligible if they have IHD, Internet access, no previous experience with cardiac rehabilitation and no physical limitations to exercise. A total of 74 patients (37 per group) will be recruited and randomized to either usual care, or a 4 month 'virtual' cardiac rehabilitation program delivered via the Internet.

Usual Care Group Patients randomized to usual care will be provided with simple guidelines for safe exercising and healthy eating habits, and return to the care of their primary care physician. Patients will return at 4 and 16 months later for outcome assessment. There will be no contact between the study personnel and usual care patients for the duration of the study, nor will there be any attempt to control the level of patient care.

Intervention The vCRP has been developed to mimic hospital-based CRP and includes online intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist, data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support group chat sessions, ask-an-expert chat sessions, education, progress reports and online resources. Upon randomization to the intervention, patients will receive access to the website, a heart rate monitor and a blood pressure monitor and trained in their use. The heart rate monitors allow for exercise heart rate data to be stored and downloaded to their home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed weekly. A letter to the patient's primary care physician will be sent to outline the vCRP intervention, the treatment algorithms to be used and indicate under what circumstances the vCRP nurse and/or patient may contact them with regards to their management. Patients will receive one-on-one counselling by the nurse, dietitian and exercise specialist via chat sessions at 3 to 4 week intervals. After the 4 month intervention, patients will be discharged into the care of their primary care physician.

Outcomes Participants will be assessed at baseline, 4 and 16 months for risk factors and lifestyle behaviours. The primary outcomes will be the change in exercise capacity as between the two groups from baseline to 4 months, and from baseline to 16 months. Exercise capacity will be assessed as total time on a symptom-limited exercise stress test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91

2. Regular Internet access (home, work or other environment).

3. Over 18 years of age.

4. Permission of the attending physician.

5. Able to read, write and understand English without difficulty.

6. No physical limitations to regular activity.

Exclusion Criteria:

1. Previous experience with a cardiac rehabilitation program.

2. Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management.

3. Those patients, who in the mind of the attending physician, are unsuitable for participation.

4. Those unable to provide informed consent.

5. Pregnant women.

6. High-risk patients for safety considerations (future studies will include high-risk patients).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• vCRP
The vCRP includes online intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist, data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support group chat sessions, ask-an-expert chat sessions, education, progress reports and online resources. VCRP patients will receive access to the website, a heart rate monitor and a blood pressure monitor and trained in their use. The heart rate monitors allow for exercise heart rate data to be stored and downloaded to their home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed weekly. A letter to the patient's primary care physician will be sent to outline the vCRP intervention, the treatment algorithms to be used and indicate under what circumstances the vCRP nurse and/or patient may contact them with regards to their management. After the 4 month intervention, patients will be discharged into the care of their primary care physician.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Simon Fraser University	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lear SA, Singer J, Banner-Lukaris D, Horvat D, Park JE, Bates J, Ignaszewski A. Randomized trial of a virtual cardiac rehabilitation program delivered at a distance via the Internet. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):952-9. doi: 10.1161/CIRCOUT — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity as reported in total time on the exercise test using the BRUCE protocol		16 months	Yes
Secondary	anthropometry		4 months	No
Secondary	blood lipids		4 months	No
Secondary	fasting blood glucose		4 months	No
Secondary	physical activity		4 months	No
Secondary	diet		4 months	No
Secondary	smoking status		4 months	No
Secondary	healthcare utilization		16 months	Yes
Secondary	exercise capacity		4 months	No
Secondary	anthropometry		16 months	No
Secondary	fasting blood glucose		16 months	No
Secondary	diet		16 months	No
Secondary	blood lipids		16 months	No
Secondary	physical activity		16 months	No
Secondary	smoking		16 months	No

External Links

•   project overview