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Completed

NCT Number: NCT07636460

The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants

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.

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Key information

Conditions

Coronary Arterial Disease (CAD) Cardiac Rehabilitation Cardiovascular Diseases Educational Intervention Heart Diseases Infarction Ischemia Ischemic Heart Disease (IHD) Myocardial Infarction Myocardial Infarction (MI) Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Audiovisual Structured Patient Education Materials

Other

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.

Standard Educational Materials

Other

Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre

Primary outcomes

  1. Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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.

Secondary outcomes

  1. Change from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2

    Time frame: Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks

    Blood glucose level through Glycated haemoglobin (HbA1c) in %

  2. Change from Baseline of Low-Density Lipoprotein Cholesterol in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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

  3. Change from Baseline of Body Fat Composition in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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.

  4. Smoking Cessation in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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).

  5. Medication Adherence in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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'.

  6. Exercise Adherence Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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.

  7. Change from Baseline in Cardiovascular Health Knowledge Assessment at 12 Weeks of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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.

  8. Understandability and Actionability of Education Materials at Completion of Cardiac Rehabilitation Programme Phase 2

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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