A Digitally-Supported Shared Decision Making Approach for... | NCT05026957

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

NCT05026957

Sponsor

Hasselt University

Status

Unknown status

Last Update Posted

Jul 24, 2023Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Cardiac Rehabilitation
Digital Health
Telerehabilitation

Interventions

SharedHeart

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Aug 12, 2021

First Submission Date that Met QC Criteria

Aug 24, 2021

First Posted Date

Aug 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2023

Last Update Posted Date

Jul 24, 2023Actual

Name	Class
Jessa Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SharedHeart	Device	A smartphone application	Control group Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Exercise capacity change	Peak VO2 with CPET	3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided