Telerehabilitation Clinical Trial
— SharedHeartOfficial 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
Verified date | July 2023 |
Source | Hasselt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigating the role of shared-decision making in cardiac rehabilitation
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Jessa Ziekenhuis | Hasselt |
Lead Sponsor | Collaborator |
---|---|
Hasselt University | Jessa Hospital |
Belgium,
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 |
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