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Completed

NCT Number: NCT04507529

Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjællands Hospital - Frederikssund, Frederikssund, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer-mentoring

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University College Copenhagen

Other

Collaborators

  • Danish Nurses Organisation
  • Nordsjaellands Hospital
  • Velux Fonden

Registry information

Official study title

'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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