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

Not Applicable

• Conditions: Ischaemic Heart Disease
• Interventions: Other: Digital Structured Patient Education Material

• Registration Number: NCT05045118
• Lead Sponsor: University of Malaya

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2021-03-30
• Status Verified: 2021-09
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Primary Completion: 2022-03-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Digital Structured Patient Education Material	Single-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material

Primary Outcome Measures

Name	Time	Method
Retention rate	3 months	The proportion of patients who completed the education material. The number of participants completed divided by the total number of participants, expressed in percentage
Cardiorespiratory fitness	3 months	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

Secondary Outcome Measures

Name	Time	Method
Compliance to medication	3 months	Compliance to daily medication will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program
Compliance to exercise	3 months	Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month
Smoking status	3 months	Smoking status will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program

Trial Locations

Locations (1)

University Malaya; 🇲🇾 Kuala Lumpur, Malaysia