E-health Intervention for Cardiac Rehabilitation

NCT03696446 | Completed

• 1 other identifier: VCRP-RCT
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac Rehabilitation; Patient Activation

Outcome Measures

Primary Outcomes (1)

• Patient Activation

  Patient activation will be measured by the Patient Activation Measure (PAM) questionnaire.This 10-item tool assesses the degree to which a patient is engaged or disengaged with their health and how likely they are to self-manage it.The total score of the tool classifies a participant into one of 4 categories; disengaged and overwhelmed (level 1), becoming aware but still struggling (level 2), taking action (level 3) and maintaining behaviors and pushing further (level 4). Higher levels mean participants are becoming better at, or have fully begun to self-manage their health behaviors.

  Baseline - 22 weeks

Secondary Outcomes (17)

• Tobacco smoking

  Baseline - 22 weeks

• Physical activity

  Baseline - 22 weeks

• Dietary behaviors

  Baseline - 22 weeks

• Medication adherence

  Baseline - 22 weeks

• Blood pressure

  Baseline - 22 weeks

Other Outcomes (1)

• Patient Experiences with the VCRP Intervention and online Platform

  Baseline - 22 weeks

Study Arms (2)

Virtual Cardiac Rehabilitation Program

EXPERIMENTAL

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

Behavioral: Virtual Cardiac Rehabilitation Program

Case Managed Home Program

OTHER

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.

Behavioral: Case Managed Home Program

Interventions

Virtual Cardiac Rehabilitation Program BEHAVIORAL

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

Also known as: Web-based CR

Virtual Cardiac Rehabilitation Program

Case Managed Home Program BEHAVIORAL

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

Also known as: Phone based CR

Case Managed Home Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient was hospitalized at the University of Ottawa Heart Institute (UOHI);
• Patient has stable Coronary Heart Disease (CHD) or valvular disease;
• Patient has been referred to Cardiac Rehabilitation (CR) and is a candidate an offsite program;
• Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
• Patient is ≥ 18 years of age (the age of consent in Ontario);
• Patient is able to read and understand English or French (programs are available in both languages);
• Patient is eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences \[ICES\]);

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

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

  PMID: 33953036 DERIVED

MeSH Terms

Conditions

Coronary Disease; Heart Valve Diseases; Patient Participation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kerri Mullen

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The facilitators will not know that the participants are part of the study. Participants will know which group they are allocated to as they are aware of both groups (described in the consent form).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: October 4, 2018
• Study Start: November 30, 2018
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)