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

Study Overview
=================
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.

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

Conditions
-----------------
Ischaemic Heart Disease

Intervention / Treatment
-----------------
* Other: Digital Structured Patient Education Material


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Single-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material | Other: Digital Structured Patient Education Material<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking status | Smoking status will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program | 3 months | 
| 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 | 
| Compliance to exercise | Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month | 3 months |