Cardiac Rehabilitation, Coronary Arterial Disease (CAD), Educational Intervention, Ischemic Heart Disease (IHD), Myocardial Infarction (MI)
Conditions
Brief 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.
Interventions
OTHERAudiovisual Structured Patient Education Materials
Bilingual (Malaysian and English language) Audiovisual Structured Patient Education Materials that are culturally adaptable on secondary prevention cardiac risk factors, self-care and exercise recommendations.
Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All of the parties are masked except the treating physician and non-participating investigator (a staff nurse), who maintained the allocation concealment list throughout the end of the trials.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2 | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | Metabolic equivalents (METs) obtained through the Exercise Stress Test (EST), employing the modified Bruce protocol. Higher metabolic equivalents of task (METs) value indicate greater energy expenditure, higher physical intensity, and generally a better level of cardiorespiratory fitness. Conversely, a lower METs value indicates lower energy expenditure, lighter activity, and potentially a poorer functional capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | Blood glucose level through Glycated haemoglobin (HbA1c) in % |
| Change from Baseline of Low-Density Lipoprotein Cholesterol in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | Blood cholesterol through Low Density Lipoprotein (LDL) cholesterol in mmol/L |
| Change from Baseline of Body Fat Composition in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | Body composition through waist circumference-to-height ratio (WHtR). Waist circumference is measured in centimetres (cm). Height is measured in centimetres (cm). Then, waist circumference-to-height will be combined and reported in a ratio. |
| Smoking Cessation in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | Smoking status and cessation were recorded weekly by self-reported statement (Smoking or Not). |
| Medication Adherence in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Assessed at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | Medication adherence was assessed at the end of Cardiac Rehabilitation Phase 2 by asking participants to indicate the likelihood of missing daily medication by using the options 'compliant', 'once a month', 'once a week', or 'more than once a week'. |
| Exercise Adherence Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Weekly assessment until the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | Exercise adherence was tracked using the provided exercise activity tracker, with adherence defined as achieving an average of at least 150 minutes of exercise per week. |
| Change from Baseline in Cardiovascular Health Knowledge Assessment at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | The Attitudes and Beliefs about Cardiovascular Disease (ABCD) risk questionnaire. Total scores range from 0 to 80 points. Higher scores indicate better overall CVD risk awareness and a greater health belief in one's capability to prevent cardiovascular disease. |
| Understandability and Actionability of Education Materials at Completion of Cardiac Rehabilitation Programme Phase 2 | At the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks | The Patient Education Materials Assessment Tool (PEMAT) is a systematic method used to evaluate and score the understandability and actionability of patient education materials. Total score of 100%, with higher percentages indicating better quality of the educational material in understandability and actionability. |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORAnwar Suhaimi
Universiti Malaya
Outcome results
None listed