E-health Intervention for Cardiac Rehabilitation

NCT ID: NCT03696446

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2022-08-23

Brief Summary

Cardiac rehabilitation (CR) is designed to increase healthy behaviours (e.g. physical activity, healthy eating, smoking abstinence) and reduce risk factors (e.g. high blood pressure & cholesterol) in order to improve quality of life and health among people with heart disease. Unfortunately, few patients attend CR, often reporting several barriers to access including travel distance, parking fees and lack of time. Advances in technology have the potential to improve accessibility and delivery of CR programs, and improve patient empowerment. The University of Ottawa Heart Institute has developed an e-health program called the Virtual Cardiac Rehabilitation Program (VCRP); an online cardiovascular health management system (website & Smartphone app) that provides strategies for the control and management of risk factors. The goals of VCRP are to: empower and educate patients; foster better communication between patients and their health care team; stimulate shared decision making; and, facilitate care coordination leading to better health outcomes. The VCRP provides patients with: real-time access to their health information, as well as tracking of risk behaviours and factors through integration with devices; a wellness plan; access to a personal on-line health coach; goal-setting notifications; on-line community forums; and, circle of care access to information. The aim of this project is to evaluate the effects of VCRP (with integrated fitness tracker) compared to a standard, home-based CR program. The study will look at changes in: patient empowerment; health behaviours; risk factors; quality of life; clinical outcomes; and, costs. The study will improve our understanding of: patient and provider needs; program usability; and shared decision-making. Results will inform the use of e-health programs such as VCRP into healthcare settings to improve patient empowerment, shared decision-making, and the ability to integrate wearable monitors to improve health behaviours.

Conditions

Coronary Heart Disease; Valve Disease, Heart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Cardiac Rehabilitation Program

This group will receive access to the NWC (NexJ Connected Wellness TM (NCW) and will be provided with a fitness tracker (Garmin Vivofit 3) to monitor their exercise, sedentary behaviours, and sleep patterns. The NWC platform includes components for education (health library, workbooks etc), collaboration (personal care plan, appointment scheduler, secure messaging system etc), and motivation (motivational messages on their homepage etc). With the Health Coach, participants will engage in: reviews of their risk factor profile and health priorities; goal setting and action planning; problem solving and skill building; and discussions of relapse prevention. Participants will receive a total of seven hours of health coaching delivered across nine sessions over a 26-week period

Group Type: EXPERIMENTAL

Virtual Cardiac Rehabilitation Program

Intervention Type: BEHAVIORAL

This group will receive their Rehab program primarily online through a secure web-based platform with a trained facilitator.

Case Managed Home Program

The Case Managed Home Program (CMHP) is delivered primarily via telephone. Following their CR intake, patients are linked with their CMHP Health Coach and attends their visit (in person or over the phone) which includes a comprehensive review of their health history, current symptoms, medications, activity, and individual concerns. Following this visit, participants will receive a total of 10 individualized telephone calls over a 26 week period. The program action plan is individually formulated based on the participant's goals and learning needs. Participants are provided with educational kits (exercise, nutrition, stress management or prevention) that are based on the principle of single point learning and incorporate behavioural change techniques.

Group Type: OTHER

Case Managed Home Program

Intervention Type: BEHAVIORAL

This group will receive their Rehab program over the phone with a trained facilitator

Interventions

Virtual Cardiac Rehabilitation Program

This group will receive their Rehab program primarily online through a secure web-based platform with a trained facilitator.

Intervention Type: BEHAVIORAL

Case Managed Home Program

This group will receive their Rehab program over the phone with a trained facilitator

Intervention Type: BEHAVIORAL

Other Intervention Names

Web-based CR; Phone based CR

Eligibility Criteria

Inclusion Criteria

1. Patient was hospitalized at the University of Ottawa Heart Institute (UOHI);

2. Patient has stable Coronary Heart Disease (CHD) or valvular disease;

3. Patient has been referred to Cardiac Rehabilitation (CR) and is a candidate an offsite program;

4. Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;

5. Patient is ≥ 18 years of age (the age of consent in Ontario);

6. Patient is able to read and understand English or French (programs are available in both languages);

7. Patient is eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]);

Exclusion Criteria

1. Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;

2. Patient, in the opinion of the medical advisor (Dr. Andrew Pipe), manifests illness that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerri Mullen

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

References

CACPR 2020 Annual Meeting Abstracts. J Cardiopulm Rehabil Prev. 2020 Nov 1;40(6):E52-E57. doi: 10.1097/HCR.0000000000000561. No abstract available.

Reference Type: DERIVED

PMID: 33953036 (View on PubMed)

Other Identifiers

VCRP-RCT

Identifier Type: -

Identifier Source: org_study_id