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Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Peer-mentoring
Sponsored by
University College Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myocardial Infarction

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nordsjællands Hospital - Frederikssund
  • Nordsjællands Hospital - Hillerød

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peer-mentoring

Arm Description

Peer-mentoring

Outcomes

Primary Outcome Measures

Recruitment
Number of patients included from eligible patients
Dropout
Number of patients not completing the intervention
Satisfaction with intervention
Semi-structured qualitative interviews with patients
Number of contacts
Number of contacts between patient and peer-mentor
Content of contacts
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'
CR attendance
Measured as 'self-reported CR attendance'
CR attendance
Measured as 'self-reported CR attendance'
Change in Health-related Quality of Life
Measured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'. Min. score: 0, max score: 42. Higher scores indicating a better outcome.
Change in Self-efficacy
Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome
Change in symptoms of anxiety and depression
Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome
Change in dietary quality
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Change in physical activity
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome

Secondary Outcome Measures

Full Information

First Posted
August 5, 2020
Last Updated
June 22, 2021
Sponsor
University College Copenhagen
Collaborators
Velux Fonden, Danish Nurses Organisation, Nordsjællands Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04507529
Brief Title
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients
Official Title
'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Copenhagen
Collaborators
Velux Fonden, Danish Nurses Organisation, Nordsjællands Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-mentoring
Arm Type
Experimental
Arm Description
Peer-mentoring
Intervention Type
Other
Intervention Name(s)
Peer-mentoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment
Description
Number of patients included from eligible patients
Time Frame
Baseline
Title
Dropout
Description
Number of patients not completing the intervention
Time Frame
24 weeks
Title
Satisfaction with intervention
Description
Semi-structured qualitative interviews with patients
Time Frame
12 weeks
Title
Number of contacts
Description
Number of contacts between patient and peer-mentor
Time Frame
24 weeks
Title
Content of contacts
Description
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'
Time Frame
24 weeks
Title
CR attendance
Description
Measured as 'self-reported CR attendance'
Time Frame
12 weeks
Title
CR attendance
Description
Measured as 'self-reported CR attendance'
Time Frame
24 weeks
Title
Change in Health-related Quality of Life
Description
Measured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'. Min. score: 0, max score: 42. Higher scores indicating a better outcome.
Time Frame
Baseline to 24 weeks
Title
Change in Self-efficacy
Description
Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome
Time Frame
Baseline to 24 weeks
Title
Change in symptoms of anxiety and depression
Description
Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome
Time Frame
Baseline to 24 weeks
Title
Change in dietary quality
Description
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Time Frame
Baseline to 24 weeks
Title
Change in physical activity
Description
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Time Frame
Baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria K Pedersen, Ph.d.
Organizational Affiliation
University College Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjællands Hospital - Frederikssund
City
Frederikssund
ZIP/Postal Code
3600
Country
Denmark
Facility Name
Nordsjællands Hospital - Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35945611
Citation
Pedersen M, Bennich B, Boateng T, Beck AM, Sibilitz K, Andersen I, Overgaard D. Peer-mentor support for older vulnerable myocardial infarction patients referred to cardiac rehabilitation: single-arm feasibility study. Pilot Feasibility Stud. 2022 Aug 9;8(1):172. doi: 10.1186/s40814-022-01141-w.
Results Reference
derived

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Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

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