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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05026957

Acronym

SharedHeart

Enrollment

Registered

2021-08-30

Start date

2022-09-01

Completion date

2024-12-31

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Rehabilitation, Digital Health, Telerehabilitation

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.

Interventions

DEVICESharedHeart

A smartphone application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

RCT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Exercise capacity change	3 months	Peak VO2 with CPET

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026