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

NCT ID: NCT05026957

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-31

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.

Conditions

Cardiac Rehabilitation; Digital Health; Telerehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Participating in regular cardiac rehabilitation

Group Type: ACTIVE_COMPARATOR

SharedHeart

Intervention Type: DEVICE

A smartphone application

Intervention

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

Group Type: EXPERIMENTAL

SharedHeart

Intervention Type: DEVICE

A smartphone application

Interventions

SharedHeart

A smartphone application

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Paul Dendale

Head of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jessa Ziekenhuis

Hasselt, , Belgium

Countries

Belgium

Other Identifiers

19.09/cardio 19.03

Identifier Type: -

Identifier Source: org_study_id