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

NCT07636460 | Completed

• 2 other identifiers: 2023717-12674PV019-2020
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Arterial Disease (CAD); Myocardial Infarction (MI); Ischemic Heart Disease (IHD); Cardiac Rehabilitation; Educational Intervention

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (8)

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

  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

  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

  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

  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

  Assessed at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group received an audiovisual version of Structured Patient Education Materials during Cardiac Rehabilitation Programme Phase 2, which were delivered via WhatsApp.

Other: Audiovisual Structured Patient Education Materials

Control

ACTIVE COMPARATOR

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.

Other: Standard Educational Materials

Interventions

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.

Intervention

Standard Educational Materials OTHER

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

Control

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- Classified as high risk according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Anwar Suhaimi

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All of the parties are masked except the treating physician and non-participating investigator (a staff nurse), who maintained the allocation concealment list throughout the end of the trials.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: June 9, 2026
• Study Start: July 19, 2023
• Primary Completion: January 8, 2025
• Study Completion: January 16, 2025
• Last Updated: June 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)