Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

• ClinicalTrials.gov Identifier: NCT04507529
• Recruitment Status: Completed
• First Posted: August 11, 2020
• Last Update Posted: June 24, 2021
• Sponsor: University College Copenhagen
• Collaborators: Velux Fonden; Danish Nurses Organisation; Nordsjællands Hospital
• Information provided by (Responsible Party): Maria Kjøller Pedersen, University College Copenhagen

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.

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction	Other: Peer-mentoring	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution
• Actual Study Start Date: September 7, 2020
• Actual Primary Completion Date: June 21, 2021
• Actual Study Completion Date: June 21, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Peer-mentoring; Peer-mentoring	Other: Peer-mentoring; 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.

Outcome Measures

Primary Outcome Measures :

1. Recruitment [ Time Frame: Baseline ]
   Number of patients included from eligible patients
2. Dropout [ Time Frame: 24 weeks ]
   Number of patients not completing the intervention
3. Satisfaction with intervention [ Time Frame: 12 weeks ]
   Semi-structured qualitative interviews with patients
4. Number of contacts [ Time Frame: 24 weeks ]
   Number of contacts between patient and peer-mentor
5. Content of contacts [ Time Frame: 24 weeks ]
   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'
6. CR attendance [ Time Frame: 12 weeks ]
   Measured as 'self-reported CR attendance'
7. CR attendance [ Time Frame: 24 weeks ]
   Measured as 'self-reported CR attendance'
8. 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.
9. Change in Self-efficacy [ Time Frame: Baseline to 24 weeks ]
   Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome
10. Change in symptoms of anxiety and depression [ Time Frame: Baseline to 24 weeks ]
    Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome
11. Change in dietary quality [ Time Frame: Baseline to 24 weeks ]
    Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
12. Change in physical activity [ Time Frame: Baseline to 24 weeks ]
    Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Denmark

Nordsjællands Hospital - Frederikssund

Frederikssund, Denmark, 3600

Nordsjællands Hospital - Hillerød

Hillerød, Denmark, 3400

Sponsors and Collaborators

University College Copenhagen

Velux Fonden

Danish Nurses Organisation

Nordsjællands Hospital

Investigators

• Principal Investigator: Maria K Pedersen, Ph.d.; University College Copenhagen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Maria Kjøller Pedersen, Assistant Professor, University College Copenhagen
• ClinicalTrials.gov Identifier: NCT04507529
• Other Study ID Numbers: Alias: 200348
• First Posted: August 11, 2020
• Last Update Posted: June 24, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases