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The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants

3 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

21

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Maleisië
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Maleisië, 50603
        • Universiti Malaya Medical Centre

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention
The intervention group received an audiovisual version of Structured Patient Education Materials during Cardiac Rehabilitation Programme Phase 2, which were delivered via WhatsApp.
Ander: Audiovisual 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.
Actieve vergelijker: 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.
Ander: Standard Educational Materials
Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
Tijdsspanne: 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.
Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tijdsspanne: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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
Tijdsspanne: 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
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
Tijdsspanne: 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.
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
Tijdsspanne: 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).
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
Tijdsspanne: 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'.
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
Tijdsspanne: 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.
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
Tijdsspanne: 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.
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
Tijdsspanne: 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.
At the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Malaya

Onderzoekers

  • Hoofdonderzoeker: Anwar Suhaimi, Universiti Malaya

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 juli 2023

Primaire voltooiing (Werkelijk)

8 januari 2025

Studie voltooiing (Werkelijk)

16 januari 2025

Studieregistratiedata

Eerst ingediend

20 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 juni 2025

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2023717-12674
  • PV019-2020 (Ander subsidie-/financieringsnummer: UMSC C.A.R.E Fund Research Grant)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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