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

Hasselt University

Status

Active, not recruiting

Conditions

Telerehabilitation

Cardiac Rehabilitation

Digital Health

Treatments

Device: SharedHeart

Study type

Interventional

Funder types

Other

Identifiers

NCT05026957

19.09/cardio 19.03

Details and patient eligibility

About

Investigating the role of shared-decision making in cardiac rehabilitation

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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