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

NCT04945486 | Completed

• 1 other identifier: Alias: 200348 RCT
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Cardiac rehabilitation attendance

  Measured as 'self-reported CR attendance'

  24 weeks

Secondary Outcomes (6)

• Change in Health-related Quality of Life

  Baseline to 24 weeks

• Change in Self-efficacy

  Baseline to 24 weeks

• Change in symptoms of anxiety and depression

  Baseline to 24 weeks

• Change in dietary quality

  Baseline to 24 weeks

• Change in physical activity

  Baseline to 24 weeks

Study Arms (2)

Peer-mentoring

EXPERIMENTAL

The patients (mentees) are matched with a peer-mentor i.e. a person with a similar life situation or health problem as one self

Other: Peer-mentor intervention

Usual care

NO INTERVENTION

Usual care provided by professional healthcare workers

Interventions

Peer-mentor intervention OTHER

Peer-mentor support for up to 6 months

Peer-mentoring

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥65 years and diagnosed with IHD and referred to CR and female or low SEP or single living or non-western background

You may not qualify if:

• Patients unable to provide written consent

Sponsors & Collaborators

• University College Copenhagen: lead
• Nordsjaellands Hospital: collaborator

Study Sites (2)

Nordsjællands Hospital - Frederikssund

Frederikssund, Denmark

Location

Nordsjællands Hospital - Hillerød

Hillerød, Denmark

Location

Related Publications (1)

• Pedersen M, Petersen RA, Boateng T, Egerod I, Overgaard D, Bennich BB. Peer-Mentor Support for Older, Vulnerable Patients With Ischemic Heart Disease: A Mixed Methods Process-Outcome Evaluation. J Adv Nurs. 2025 Dec;81(12):8946-8958. doi: 10.1111/jan.16899. Epub 2025 Mar 17.

  PMID: 40095257 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: August 2, 2021
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)