The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants
3 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
21
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malásia, 50603
- Universiti Malaya Medical Centre
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
Prazo: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Prazo: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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
Prazo: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Blood cholesterol through Low Density Lipoprotein (LDL) cholesterol in mmol/L
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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 Body Fat Composition in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
Prazo: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Anwar Suhaimi, Universiti Malaya
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de julho de 2023
Conclusão Primária (Real)
8 de janeiro de 2025
Conclusão do estudo (Real)
16 de janeiro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
20 de novembro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de junho de 2026
Primeira postagem (Real)
9 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de junho de 2026
Última verificação
1 de junho de 2025
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2023717-12674
- PV019-2020 (Número de outro subsídio/financiamento: UMSC C.A.R.E Fund Research Grant)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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