A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation

Study Overview
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Brief Summary
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Investigating the role of shared-decision making in cardiac rehabilitation

Detailed Description
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The clinical study is a prospective double-arm, randomized controlled trial to study the user experience of the approach with the supporting applications, and the impact on patients' quality of life, physical activity, perception of rehabilitation and engagement in the decision making process.

Official Title
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A Shared Decision Making Approach With Digital Support to Improve Quality of Life, Exercise Capacity, Motivation to Exercise, Perception of Rehabilitation and Engagement in the Decision Making Process in Patients With Coronary Artery Disease in a Cardiac Rehabilitation Setting

Conditions
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Cardiac Rehabilitation, Digital Health, Telerehabilitation

Intervention / Treatment
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* Device: SharedHeart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a history of coronary artery disease with or without intervention (PCI/CABG/conservative) Be clinically stable without inducible ischemia or high risk ventricular arrhythmia, confirmed by the last available maximal ergospirometry test Recently having started cardiac rehabilitation in Jessa Hospital Hasselt Age ≥18 years Willing and physically able to follow a technology-supported shared decision making program and other study procedures in a three months follow-up period Show evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study Possession of and/or able to use an Android based smartphone Possession of internet connectivity Dutch speaking and understanding Exclusion Criteria: • Orthopedic, neurologic or any other pathologic condition which makes the patient physically unable to follow a technology-supported shared decision making program Planned interventional procedure or surgery in the next three months Pregnant females Present cardiovascular complaints Participation in other cardiac rehabilitation program trials, focusing on exercise outcome Current or recent participation in other technology-supported programs, even when not directly targeting exercise capacity Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than three months based on investigators judgement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Participating in regular cardiac rehabilitation | Device: SharedHeart<br>* A smartphone application<br>|
| Experimental: Intervention<br>Participating in regular cardiac rehabilitation + using the shared-decision making application | Device: SharedHeart<br>* A smartphone application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart-related Quality of Life | The Heart-related Quality of Life will be assesed with a validated questionnaire HeartQoL. The questionnaire will be administered to the patient at baseline and after 3 months on paper. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity change | Peak VO2 with CPET | 3 months |