The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants
3 juni 2026 uppdaterad av: University of Malaya
The Impact of Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants: A Randomised Controlled Trial Study
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
21
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
- Universiti Malaya Medical Centre
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention
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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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.
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Aktiv komparator: Control
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.
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Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
Tidsram: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsram: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Blood glucose level through Glycated haemoglobin (HbA1c) in %
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Change from Baseline of Low-Density Lipoprotein Cholesterol in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsram: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Blood cholesterol through Low Density Lipoprotein (LDL) cholesterol in mmol/L
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
|
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Change from Baseline of Body Fat Composition in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsram: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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.
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Smoking Cessation in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsram: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Smoking status and cessation were recorded weekly by self-reported statement (Smoking or Not).
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Medication Adherence in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsram: Assessed at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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'.
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Assessed at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Exercise Adherence Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsram: Weekly assessment until the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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.
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Weekly assessment until the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Change from Baseline in Cardiovascular Health Knowledge Assessment at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsram: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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.
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Understandability and Actionability of Education Materials at Completion of Cardiac Rehabilitation Programme Phase 2
Tidsram: At the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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.
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At the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Anwar Suhaimi, Universiti Malaya
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 juli 2023
Primärt slutförande (Faktisk)
8 januari 2025
Avslutad studie (Faktisk)
16 januari 2025
Studieregistreringsdatum
Först inskickad
20 november 2025
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
9 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juni 2026
Senast verifierad
1 juni 2025
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2023717-12674
- PV019-2020 (Annat bidrag/finansieringsnummer: UMSC C.A.R.E Fund Research Grant)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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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