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

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

Investigating the role of shared-decision making in cardiac rehabilitation

Study Overview

• Status: Active, not recruiting
• Conditions: Telerehabilitation; Cardiac Rehabilitation; Digital Health
• Intervention / Treatment: Device: SharedHeart

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium
    • Jessa Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 19.09/cardio 19.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No