- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04507529
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients
'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution
BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an increasingly older myocardial infarction (MI) population in need of cardiac rehabilitation (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established; CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life among patients with ischemic heart disease. These positive effects of CR has also been established among older patients. The inherent problem lies in the low attendance rate, often below 50%. Several studies, including studies from Denmark, have shown that low participation in CR is most prevalent among older, vulnerable female patients. The notion vulnerable covers patients with low socioeconomic position (SEP), patients with non-western background and patients living alone, as these groups have particularly low CR attendance. Effective interventions aiming at increasing CR attendance among these low attending groups are thus warranted and the current study will seek to address this.
AIM: To test feasibility and acceptability of methods used in a peer-mentor intervention among older female and vulnerable post MI patients.
DESIGN AND METHODS: The study is designed as a one arm feasibility study. Patients (n=20) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital. Data is collected at three timepoints, baseline, 12 weeks and 24 weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring by a person with a similar life situation or health problem as one self) is a low-cost intervention that holds the potential to improve CR attendance and improve physical and psychological outcomes among older patients. Peer-mentors are role models who can guide and support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR setting among older, female and vulnerable MI patients; establishing the novelty of the current study.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Frederikssund, Denmark, 3600
- Nordsjællands Hospital - Frederikssund
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Hillerød, Denmark, 3400
- Nordsjællands Hospital - Hillerød
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥65 years and diagnosed with MI and referred to CR and female or low SEP or single living or non-western background.
Exclusion Criteria:
- Patients unable to provide written consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peer-mentoring
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Patients (mentees) are matched with a peer-mentor.
Throughout the intervention period (24 weeks), the mentee and the mentor will have informal telephone contact and meet face-to face approximately 8 times during the intervention period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health-related Quality of Life
Time Frame: Baseline to 24 weeks
|
Measured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'.
Min.
score: 0, max score: 42.
Higher scores indicating a better outcome.
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Baseline to 24 weeks
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Change in Self-efficacy
Time Frame: Baseline to 24 weeks
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Measured using the questionnaire 'General self-efficacy scale'.
Min score: 10, max score: 40.
Higher scores indicating a better outcome
|
Baseline to 24 weeks
|
Change in symptoms of anxiety and depression
Time Frame: Baseline to 24 weeks
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Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS).
Min.
score: 0, max score 42.
Lower scores indicating a better outcome
|
Baseline to 24 weeks
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Change in dietary quality
Time Frame: Baseline to 24 weeks
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Measured using the questionnaire 'Heartdiet'.
Higher scores indicating a better outcome
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Baseline to 24 weeks
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Change in physical activity
Time Frame: Baseline to 24 weeks
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Measured using the questionnaire 'Heartdiet'.
Higher scores indicating a better outcome
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Baseline to 24 weeks
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Recruitment
Time Frame: Baseline
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Number of patients included from eligible patients
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Baseline
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Dropout
Time Frame: 24 weeks
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Number of patients not completing the intervention
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24 weeks
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Satisfaction with intervention
Time Frame: 12 weeks
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Semi-structured qualitative interviews with patients
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12 weeks
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Number of contacts
Time Frame: 24 weeks
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Number of contacts between patient and peer-mentor
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24 weeks
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Content of contacts
Time Frame: 24 weeks
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Content of contacts between patient and peer-mentor will be assessed through open ended question on questionnaire i.e. 'What was the content of your meeting?
e.g face-to-face meeting with conversation about everyday life'
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24 weeks
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CR attendance
Time Frame: 12 weeks
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Measured as 'self-reported CR attendance'
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12 weeks
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CR attendance
Time Frame: 24 weeks
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Measured as 'self-reported CR attendance'
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24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria K Pedersen, Ph.d., University College Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alias: 200348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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