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

Primary Purpose

Cardiac Rehabilitation, Digital Health, Telerehabilitation

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SharedHeart
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jessa Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention

Arm Description

Participating in regular cardiac rehabilitation

Participating in regular cardiac rehabilitation + using the shared-decision making application

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Exercise capacity change
Peak VO2 with CPET

Full Information

First Posted
August 12, 2021
Last Updated
July 21, 2023
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05026957
Brief Title
A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Rehabilitation, Digital Health, Telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participating in regular cardiac rehabilitation
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participating in regular cardiac rehabilitation + using the shared-decision making application
Intervention Type
Device
Intervention Name(s)
SharedHeart
Intervention Description
A smartphone application
Primary Outcome Measure Information:
Title
Heart-related Quality of Life
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Exercise capacity change
Description
Peak VO2 with CPET
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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