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

September 6, 2021 updated by: University of Malaya
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anie Farhana Ngimron, MBBChBAO
        • Principal Investigator:
          • Anwar Suhaimi, MD, MRehabMed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention arm
Single-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate
Time Frame: 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
3 months
Cardiorespiratory fitness
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking status
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2021

Primary Completion (ANTICIPATED)

March 30, 2022

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (ACTUAL)

September 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MREC ID: 20201010-9146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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