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| ID | Type | Description | Link |
|---|---|---|---|
| PV019-2020 | Other Grant/Funding Number | UMSC C.A.R.E Fund Research Grant |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention group received an audiovisual version of Structured Patient Education Materials during Cardiac Rehabilitation Programme Phase 2, which were delivered via WhatsApp. |
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| Control | Active Comparator | The control group received the standard visual-based educational materials currently used in UMMC's Cardiac Rehabilitation Program Phase 2, which were delivered via WhatsApp. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audiovisual Structured Patient Education Materials | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2 | 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. | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Blood glucose level through Glycated haemoglobin (HbA1c) in % | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Change from Baseline of Low-Density Lipoprotein Cholesterol in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 |
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Inclusion Criteria:
Exclusion Criteria
- Classified as high risk according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR)
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| Name | Affiliation | Role |
|---|---|---|
| Anwar Suhaimi | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Malaya Medical Centre | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
IPD will not be shared with outside researchers, as the informed consent forms for this study did not include a provision for future sharing of individual participant data beyond the initial research team. Therefore, IPD cannot be shared to protect participant autonomy.
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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.
| Standard Educational Materials | Other | Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre |
|
Blood cholesterol through Low Density Lipoprotein (LDL) cholesterol in mmol/L |
| Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Change from Baseline of Body Fat Composition in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | 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. | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Smoking Cessation in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | Smoking status and cessation were recorded weekly by self-reported statement (Smoking or Not). | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Medication Adherence in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | 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'. | Assessed at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Exercise Adherence Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | 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. | Weekly assessment until the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Change from Baseline in Cardiovascular Health Knowledge Assessment at 12 Weeks of Cardiac Rehabilitation Programme Phase 2 | 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. | Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| Understandability and Actionability of Education Materials at Completion of Cardiac Rehabilitation Programme Phase 2 | 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. | At the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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