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

NCT05026957 | Unknown

• 1 other identifier: 19.09/cardio 19.03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Investigating the role of shared-decision making in cardiac rehabilitation

Conditions

Cardiac Rehabilitation; Digital Health; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exercise capacity change

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Participating in regular cardiac rehabilitation

Device: SharedHeart

Intervention

EXPERIMENTAL

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

Device: SharedHeart

Interventions

SharedHeart DEVICE

A smartphone application

Control group; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Model Details: RCT

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 30, 2021
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)