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Completed

NCT Number: NCT00683813

Trial of a Cardiac Rehabilitation Program Delivered Remotely Through the Internet

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91
  • Regular Internet access (home, work or other environment).
  • Over 18 years of age.
  • Permission of the attending physician.
  • Able to read, write and understand English without difficulty.
  • No physical limitations to regular activity.

Exclusion criteria

  • Previous experience with a cardiac rehabilitation program.
  • Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management.
  • Those patients, who in the mind of the attending physician, are unsuitable for participation.
  • Those unable to provide informed consent.
  • Pregnant women.
  • High-risk patients for safety considerations (future studies will include high-risk patients).

Treatment and study plan

vCRP

Behavioral

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.

Primary outcomes

  1. exercise capacity as reported in total time on the exercise test using the BRUCE protocol

    Time frame: 16 months

Secondary outcomes

  1. anthropometry

    Time frame: 4 months

  2. blood lipids

    Time frame: 4 months

  3. fasting blood glucose

    Time frame: 4 months

  4. physical activity

    Time frame: 4 months

  5. diet

    Time frame: 4 months

  6. smoking status

    Time frame: 4 months

  7. healthcare utilization

    Time frame: 16 months

  8. exercise capacity

    Time frame: 4 months

  9. anthropometry

    Time frame: 16 months

  10. fasting blood glucose

    Time frame: 16 months

  11. diet

    Time frame: 16 months

  12. blood lipids

    Time frame: 16 months

  13. physical activity

    Time frame: 16 months

  14. smoking

    Time frame: 16 months

Sponsors and collaborators

Lead sponsor

Simon Fraser University

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Official study title

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

Acronym: vCRP

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 23, 2008
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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