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

NCT ID: NCT04945486

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2023-08-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Peer-mentoring

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

Group Type: EXPERIMENTAL

Peer-mentor intervention

Intervention Type: OTHER

Peer-mentor support for up to 6 months

Usual care

Usual care provided by professional healthcare workers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer-mentor intervention

Peer-mentor support for up to 6 months

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordsjaellands Hospital

OTHER

Sponsor Role: collaborator

University College Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Maria Kjøller Pedersen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nordsjællands Hospital - Frederikssund

Frederikssund, , Denmark

Nordsjællands Hospital - Hillerød

Hillerød, , Denmark

Countries

Denmark

References

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 Mar 17. doi: 10.1111/jan.16899. Online ahead of print.

Reference Type: DERIVED

PMID: 40095257 (View on PubMed)

Other Identifiers

Alias: 200348 RCT

Identifier Type: -

Identifier Source: org_study_id