The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants
3 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malasia, 50603
- Universiti Malaya Medical Centre
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Anwar Suhaimi, Universiti Malaya
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de julio de 2023
Finalización primaria (Actual)
8 de enero de 2025
Finalización del estudio (Actual)
16 de enero de 2025
Fechas de registro del estudio
Enviado por primera vez
20 de noviembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de junio de 2025
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2023717-12674
- PV019-2020 (Otro número de subvención/financiamiento: UMSC C.A.R.E Fund Research Grant)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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