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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04945486
Enrollment
117
Registered
2021-06-30
Start date
2021-08-02
Completion date
2023-08-25
Last updated
2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Brief summary

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.

Interventions

OTHERPeer-mentor intervention

Peer-mentor support for up to 6 months

Sponsors

Nordsjaellands Hospital
CollaboratorOTHER
University College Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Masking is not possible

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac rehabilitation attendance24 weeksMeasured as 'self-reported CR attendance'

Secondary

MeasureTime frameDescription
Change in Self-efficacyBaseline to 24 weeksMeasured 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 depressionBaseline to 24 weeksMeasured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome
Change in Health-related Quality of LifeBaseline to 24 weeksMeasured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'. Min. score: 0, max score: 42. Higher scores indicating a better outcome.
Change in physical activityBaseline to 24 weeksMeasured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Qualitative content of disease trajectoryBaseline to 24 weeksSemi-structured qualitative interviews with patients (n=20-25)
Change in dietary qualityBaseline to 24 weeksMeasured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026