Back to resultsThe Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study
Primary Purpose
Ischaemic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Digital Structured Patient Education Material
Sponsored by
About this trial
This is an interventional prevention trial for Ischaemic Heart Disease
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
Sites / Locations
- University MalayaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Single-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Smoking status
Smoking status will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program
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
Compliance to exercise
Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month
Full Information
NCT ID
NCT05045118
First Posted
September 1, 2021
Last Updated
September 6, 2021
Sponsor
University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT05045118
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemic Heart Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Single-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material
Intervention Type
Other
Intervention Name(s)
Digital Structured Patient Education Material
Intervention Description
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
Primary Outcome Measure Information:
Title
Retention rate
Description
The proportion of patients who completed the education material. The number of participants completed divided by the total number of participants, expressed in percentage
Time Frame
3 months
Title
Cardiorespiratory fitness
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Smoking status
Description
Smoking status will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program
Time Frame
3 months
Title
Compliance to medication
Description
Compliance to daily medication will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program
Time Frame
3 months
Title
Compliance to exercise
Description
Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Malaya
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anie Farhana Ngimron, MBBChBAO
Phone
+60136228602
Email
aniefarhana@ummc.edu.my
First Name & Middle Initial & Last Name & Degree
Anwar Suhaimi, MD, MRehabMed
Phone
+60166591383
Email
anwar@ummc.edu.my
First Name & Middle Initial & Last Name & Degree
Anie Farhana Ngimron, MBBChBAO
First Name & Middle Initial & Last Name & Degree
Anwar Suhaimi, MD, MRehabMed
12. IPD Sharing Statement
Learn more about this 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
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