Clinical trial NCT05026957: A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Digital Health
Telerehabilitation
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2021-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart-related Quality of Life
timeFrame: 3 months
Secondary outcomes:
measure: Exercise capacity change
timeFrame: 3 months
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
References: