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Trial record 1 of 1 for:    NCT04507529
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Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04507529
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : June 24, 2021
Velux Fonden
Danish Nurses Organisation
Nordsjællands Hospital
Information provided by (Responsible Party):
Maria Kjøller Pedersen, University College Copenhagen

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04507529

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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
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Principal Investigator: Maria K Pedersen, Ph.d. University College Copenhagen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maria Kjøller Pedersen, Assistant Professor, University College Copenhagen Identifier: NCT04507529    
Other Study ID Numbers: Alias: 200348
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases