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NCT Number: NCT04945486

The Effect of Peer-mentor Support for Older Vulnerable Patients With Ischemic Heart Disease

BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an increasingly older Ischemic Heart Disease (IHD) 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 IHD. 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 and 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 the effect of a peer-mentor intervention among older vulnerable IHD patients.

DESIGN AND METHODS: The study is designed as a two arm RCT-study applying mixed methods.

Power calculations were based upon primary outcome 'Cardiac rehabilitation (CR) attendance'. Proportion attending CR in control group was set at 25% and intervention group at 50% based upon previous research. With a 5% significance level and 80% power. 110 patients were required (55 in each group) to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 25% in the control group to 50% in the experimental group.

Expected dropout was 6%. I.e., in total 117 patients are enrolled.

Patients (n=117) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital and randomized (with 1:1 individual randomisation) to peer-mentor intervention or usual care. Data is collected through both qualitative and quantitative data (mixed methods). 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 IHD 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 IHD 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-mentor intervention

Other

Peer-mentor support for up to 6 months

Primary outcomes

  1. Cardiac rehabilitation attendance

    Time frame: 24 weeks

    Measured as 'self-reported CR attendance'

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. Change in dietary quality

    Time frame: Baseline to 24 weeks

    Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome

  5. Change in physical activity

    Time frame: Baseline to 24 weeks

    Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome

  6. Qualitative content of disease trajectory

    Time frame: Baseline to 24 weeks

    Semi-structured qualitative interviews with patients (n=20-25)

Sponsors and collaborators

Lead sponsor

University College Copenhagen

Other

Collaborators

  • Nordsjaellands Hospital

Registry information

Official study title

The Effect of a Peer-mentor Intervention on Inequality in Cardiac Rehabilitation Attendance: a Mixed Method Intervention Study Among Older Vulnerable Patients With Ischemic Heart Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2021
Registry last updated
Sep 15, 2023

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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