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

Not Applicable

Active, not recruiting

• Conditions: Digital Health; Telerehabilitation; Cardiac Rehabilitation
• Interventions: Device: SharedHeart

• Registration Number: NCT05026957
• Lead Sponsor: Hasselt University

Brief Summary

Investigating the role of shared-decision making in cardiac rehabilitation

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 Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Study Start: 2022-09-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	SharedHeart	Participating in regular cardiac rehabilitation
Intervention	SharedHeart	Participating in regular cardiac rehabilitation + using the shared-decision making application

Primary Outcome Measures

Name	Time	Method
Heart-related Quality of Life	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Exercise capacity change	3 months	Peak VO2 with CPET

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium