Ischaemic Heart DiseaseNCT05045118
The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study
A study testing Digital Structured Patient Education Material in people with Ischaemic Heart Disease, run by University of Malaya at 1 site in Malaysia.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischaemic Heart Disease
- What is being tested?
- Digital Structured Patient Education Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Mar 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Stratified as high risk to participate in an aerobic exercise program as per the American Association of cardiovascular and Pulmonary Rehabilitation standards
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya
Kuala Lumpur, 59100
Anie Farhana Ngimron, MBBChBAO, +60136228602, aniefarhana@ummc.edu.my
Anwar Suhaimi, MD, MRehabMed, +60166591383, anwar@ummc.edu.my
About this study
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
Read the 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.
- Conditions
- Ischaemic Heart Disease
- Being tested
- Digital Structured Patient Education Material
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Structured Patient Education MaterialOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Single-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material Receives: Other: Digital Structured Patient Education Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (3)
Smoking status
Smoking status will be recorded as reported by patient upon recruitment, and at 1st, 2nd and 3rd month of program
Measured: 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
Measured: 3 months
Compliance to exercise
Number of hours of performing aerobic exercise per week upon recruitment, at 1st, 2nd, 3rd month
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Mar 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045118
- Sponsor's protocol ID
- MREC ID: 20201010-9146
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05045118
- Acronym / sponsor ID
- MREC ID: 20201010-9146
- Conditions
- Ischaemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Digital Structured Patient Education MaterialSingle-arm prospective, multiple assessment intervention study. Participants will receive a digital structured patient education material |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Stratified as high risk to participate in an aerobic exercise program as per the American Association of cardiovascular and Pulmonary Rehabilitation standards
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Structured Patient Education MaterialParticipants 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 | Other | Intervention arm |
Primary outcome
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
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 secondary outcomes
Smoking status
Time frame: 3 months
Compliance to medication
Time frame: 3 months
Compliance to exercise
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Structured Patient Education Material in people with Ischaemic Heart Disease, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.