Cardiac RehabilitationSharedHeartNCT05026957
A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation
A study testing SharedHeart in people with Cardiac Rehabilitation and Digital Health, run by Hasselt University at 1 site in Belgium.
Trial summary
Investigating the role of shared-decision making in cardiac rehabilitation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Digital Health, Telerehabilitation
- What is being tested?
- SharedHeart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Possession of and/or able to use an Android based smartphone
- Possession of internet connectivity
- Dutch speaking and understanding
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Investigating the role of shared-decision making in cardiac rehabilitation
Read the 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
- Being tested
- SharedHeart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SharedHeartDevice
A smartphone application
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participating in regular cardiac rehabilitation Receives: Device: SharedHeart |
| Intervention | Experimental | Participating in regular cardiac rehabilitation + using the shared-decision making application Receives: Device: SharedHeart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Exercise capacity change
Peak VO2 with CPET
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026957
- Sponsor's protocol ID
- 19.09/cardio 19.03
- Acronym
- SharedHeart
- Status last verified
- Jul 2023
- First submitted
- 12 Aug 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05026957
- Acronym / sponsor ID
- SharedHeart / 19.09/cardio 19.03
- Conditions
- Cardiac Rehabilitation, Digital Health, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: SharedHeartParticipating in regular cardiac rehabilitation |
| Intervention | Experimental | Device: SharedHeartParticipating in regular cardiac rehabilitation + using the shared-decision making application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- • Orthopedic, neurologic or any other pathologic condition which makes the patient physically unable to follow a technology-supported shared decision making program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SharedHeartA smartphone application | Device | Control group, Intervention |
Primary outcome
Heart-related Quality of Life
Time frame: 3 months
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.
1 secondary outcome
Exercise capacity change
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SharedHeart in people with Cardiac Rehabilitation and Digital Health, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart-related Quality of Life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.