Clinical trial NCT03696446: E-health Intervention for Cardiac Rehabilitation
Official title: E-health Intervention for Cardiac Rehabilitation: Pilot Implementation and Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Valve Disease, Heart
Keywords: Cardiac Rehabilitation
Patient Activation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Patient Activation
timeFrame: Baseline - 22 weeks
Secondary outcomes:
measure: Tobacco smoking
timeFrame: Baseline - 22 weeks
measure: Physical activity
timeFrame: Baseline - 22 weeks
measure: Dietary behaviors
timeFrame: Baseline - 22 weeks
measure: Medication adherence
timeFrame: Baseline - 22 weeks
measure: Blood pressure
timeFrame: Baseline - 22 weeks
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline - 22 weeks
measure: High density lipoprotein cholesterol (HDL-C)
timeFrame: Baseline - 22 weeks
measure: Total cholesterol (TC)
timeFrame: Baseline - 22 weeks
measure: Triglycerides
timeFrame: Baseline - 22 weeks
measure: Glycated hemoglobin (A1C)
timeFrame: Baseline - 22 weeks
measure: Waist circumference
timeFrame: Baseline - 22 weeks
measure: Generic Quality of Life
timeFrame: Baseline - 22 weeks
measure: Health Related Quality of Life
timeFrame: Baseline - 22 weeks
measure: Clinical outcomes - Re-hospitalization
timeFrame: Baseline - 52 weeks
measure: Clinical outcome - Health care utilization - Number of emergency room and physician visits
timeFrame: Baseline - 52 weeks
measure: Clinical outcome - mortality
timeFrame: Baseline - 52 weeks
measure: Cost of Intervention
timeFrame: Fiscal year 2017 through study completion.
Other outcomes:
measure: Patient Experiences with the VCRP Intervention and online Platform
timeFrame: Baseline - 22 weeks
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Kerri Mullen
role: PRINCIPAL_INVESTIGATOR
References:
citation: CACPR 2020 Annual Meeting Abstracts. J Cardiopulm Rehabil Prev. 2020 Nov 1;40(6):E52-E57. doi: 10.1097/HCR.0000000000000561. No abstract available.