A Digitally-Supported Shared Decision Making Approach for Patients during Cardiac Rehabilitation: Protocol for a Randomized Controlled Trial.

Abstract Background : Physical activity is a key component of cardiac rehabilitation. However, EUROASPIRE V concluded that intending 48% of coronary artery disease (CAD) patients do not intend to do physical activity in the next six months. Patient involvement improves patient satisfaction, adherence, and health outcomes and is a prerequisite for good clinical practice. Unfortunately, patients currently have only limited input in their exercise prescription. We developed SharedHeart, a digitally-supported shared decision making (SDM) approach that assists patients with heart disease and their caregivers in collaboratively setting up exercise goals and creating an exercise plan for the patient. Objective : The aim of the study is to determine the effectiveness and cost-effectiveness of the combination of center-based CR and shared decision making based telerehabilitation. The study investigates the influence of a SDM approach supported by digital applications on the patient’s quality of life, exercise capacity, motivation to exercise, perception of rehabilitation and engagement in the shared decision making process. Methods : The study is a prospective double-arm, randomized controlled trial that includes a usability study of the applications. In the usability study, instantaneous user friendliness and patients’ motivation will be investigated by testing the designed applications with 10 CAD patients and 5 physiotherapists. In the RCT, 80 patients will be randomized 1:1 between an intervention group and a control group. The intervention group will follow the SharedHeart approach, consisting of SDM encounters with caregivers and using the digital tools during phase II cardiac rehabilitation (i.e. 3 months). The primary outcome measure is patients’ quality of life, assessed with the HeartQoL questionnaire. Secondary outcomes are related to patients’ exercise capacity, motivation to exercise, perception of rehabilitation and engagement in the shared decision-making process. All methods were performed in accordance with the relevant guidelines and regulations by including a statement in the Ethics approval and consent to participate section to this effect. Discussion : This will be one of the first study to investigate the effects of a digitally-supported shared decision making approach. If the SharedHeart approach and supporting applications are found to be effective in increasing patients’ quality of life, exercise capacity, motivation to exercise, perception of rehabilitation and/or engagement in the shared decision making process, this can be a cost-effective and accessible solution to increase patient outcomes and patient involvement during cardiac rehabilitation. Trial registration: ClinicalTrials.gov NCT05026957.