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

Telerehabilitation Clinical Trial

— SharedHeart  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05026957
• Other study ID #: 19.09/cardio 19.03
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating the role of shared-decision making in cardiac rehabilitation

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Coronary Artery Disease
• Coronary Disease
• Digital Health
• Myocardial Ischemia
• Telerehabilitation

Intervention

Device:
• SharedHeart
A smartphone application

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Exercise capacity change	Peak VO2 with CPET	3 months