The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2021
CompletedFirst Submitted
Initial submission to the registry
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedSeptember 16, 2021
September 1, 2021
1 year
September 1, 2021
September 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Smoking status
3 months
Compliance to medication
3 months
Compliance to exercise
3 months
Study Arms (1)
Intervention arm
EXPERIMENTALSingle-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Stratified as high risk to participate in an aerobic exercise program as per the American Association of cardiovascular and Pulmonary Rehabilitation standards
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Malaya
Kuala Lumpur, 59100, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2021
First Posted
September 16, 2021
Study Start
March 30, 2021
Primary Completion
March 30, 2022
Study Completion
June 30, 2022
Last Updated
September 16, 2021
Record last verified: 2021-09