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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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
The intervention group received an audiovisual version of Structured Patient Education Materials during Cardiac Rehabilitation Programme Phase 2, which were delivered via WhatsApp.
Altro: 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.
Comparatore attivo: 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.
Altro: Standard Educational Materials
Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Malaya

Investigatori

  • Investigatore principale: Anwar Suhaimi, Universiti Malaya

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 luglio 2023

Completamento primario (Effettivo)

8 gennaio 2025

Completamento dello studio (Effettivo)

16 gennaio 2025

Date di iscrizione allo studio

Primo inviato

20 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2025

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2023717-12674
  • PV019-2020 (Altro numero di sovvenzione/finanziamento: UMSC C.A.R.E Fund Research Grant)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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