The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants
3. juni 2026 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
21
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
- Universiti Malaya Medical Centre
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention
The intervention group received an audiovisual version of Structured Patient Education Materials during Cardiac Rehabilitation Programme Phase 2, which were delivered via WhatsApp.
|
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.
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Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 %
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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
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.
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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
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
|
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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'.
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Anwar Suhaimi, Universiti Malaya
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. juli 2023
Primær fullføring (Faktiske)
8. januar 2025
Studiet fullført (Faktiske)
16. januar 2025
Datoer for studieregistrering
Først innsendt
20. november 2025
Først innsendt som oppfylte QC-kriteriene
3. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juni 2026
Sist bekreftet
1. juni 2025
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023717-12674
- PV019-2020 (Annet stipend/finansieringsnummer: UMSC C.A.R.E Fund Research Grant)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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