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NCT05045118 Clinical Trial

The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study

Ischaemic Heart Disease Clinical Trial

Official title:
The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05045118
Other study ID # MREC ID: 20201010-9146
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2021
Est. completion date June 30, 2022

Study information
Verified date September 2021
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine the impact of providing a digital education material to participants of home based cardiac rehabilitation in improving clinical and behavioural outcomes

Description:

This is a pilot study aiming to assess the impact of providing a structured patient education material in a digital form to participants of home based cardiac rehabilitation program in University Malaya Medical Centre.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - Age 20-70 years - Fulfills the low to moderate exercise participation risk criteria for Cardiac rehabilitation program phase 2 as per the American Association of Cardiovascular and Pulmonary Rehabilitation standards - Able to participate in a treadmill exercise program - Cognitively able to give consent, and able to read and utilize the digital education material Exclusion Criteria: - Stratified as high risk to participate in an aerobic exercise program as per the American Association of cardiovascular and Pulmonary Rehabilitation standards

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Digital Structured Patient Education Material
Participants of home-based Cardiac Rehabilitation Program that are included in this research will be provided with a digital Structured Patient Education Material at the beginning of the program, and will be followed up for 12 weeks duration

Locations
Country Name City State
Malaysia University Malaya Kuala Lumpur

Sponsors (1)
Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retention rate The proportion of patients who completed the education material. The number of participants completed divided by the total number of participants, expressed in percentage 3 months
Primary Cardiorespiratory fitness Peak METs and HRmax measured by exercise stress testing, to estimate VO2 max. This measurement is recorded at pre and post 12 weeks of intervention 3 months
Secondary Smoking status Smoking status will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program 3 months
Secondary Compliance to medication Compliance to daily medication will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program 3 months
Secondary Compliance to exercise Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month 3 months
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