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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
The intervention group received an audiovisual version of Structured Patient Education Materials during Cardiac Rehabilitation Programme Phase 2, which were delivered via WhatsApp.
Andet: 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.
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.
Andet: Standard Educational Materials
Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaya

Efterforskere

  • Ledende efterforsker: Anwar Suhaimi, Universiti Malaya

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. juli 2023

Primær færdiggørelse (Faktiske)

8. januar 2025

Studieafslutning (Faktiske)

16. januar 2025

Datoer for studieregistrering

Først indsendt

20. november 2025

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023717-12674
  • PV019-2020 (Andet bevillings-/finansieringsnummer: UMSC C.A.R.E Fund Research Grant)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hjerterehabilitering

Kliniske forsøg med Audiovisual Structured Patient Education Materials

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner