The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavio… (NCT07636460) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants
Malaysia21 participantsStarted 2023-07-19
Plain-language summary
The goal of this clinical trial is to find out if newly developed, culturally adapted educational videos-sent through a mobile messaging app-can help people with coronary heart disease do better in a home-based cardiac rehabilitation program in Malaysia.
The main questions it aims to answer are:
* Do the educational videos help participants improve their fitness?
* Do the videos help participants better understand heart health and stick to a healthy lifestyle?
Researchers will compare the educational videos to existing standard educational materials to see if the video-based education is more helpful for supporting rehabilitation at home.
Participants will:
* Take part in a 12-week home-based cardiac rehabilitation program
* Receive either educational videos or standard education materials
* Meet with the cardiac rehabilitation team every 4 weeks
* Complete a treadmill exercise test, blood tests, and questionnaires before and after the program.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed as any form of ischaemic heart disease;
* Classified as low to moderate risk based on American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) criteria through Exercise Stress Test (EST);
* Cognitively intact and able to provide informed consent;
* Literate and capable of utilising educational material;
* Able to use and operate a smartphone with an exercise activity tracker (EAT).
Exclusion Criteria
\- Classified as high risk according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed, would it be possible to see the results — specifically whether the audiovisual education materials actually improved cardiovascular fitness scores (METs) compared to standard care, and what that might mean for my own rehab program?
2This trial focused on home-based cardiac rehabilitation rather than in-person sessions — given my specific diagnosis of coronary artery disease or recent heart attack, do you think a home-based rehab approach with structured educational materials would be appropriate for me, or would an in-person program be safer?
3The trial measured fitness improvement using metabolic equivalents (METs) — can you explain what my current MET level is and how much improvement would be considered meaningful progress during Phase 2 of cardiac rehab?
4Since this was a Phase NA study focused on an educational intervention rather than a drug or device, what does the evidence say about whether structured audiovisual patient education actually changes real-world behaviors and long-term heart health outcomes for people in my situation?
5Are there already established cardiac rehabilitation programs at this hospital or clinic that incorporate structured patient education similar to what was tested in this trial, so I don't have to wait for research findings to access that kind of support?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
Timeframe: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks