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

Ischemic Heart Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04945486
• Other study ID #: Alias: 200348 RCT
• Status: Completed
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: August 25, 2023

Study information

• Verified date: September 2023
• Source: University College Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Peer-mentor intervention
Peer-mentor support for up to 6 months

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital - Frederikssund	Frederikssund
Denmark	Nordsjællands Hospital - Hillerød	Hillerød

Sponsors (2)

Lead Sponsor	Collaborator
University College Copenhagen	Nordsjællands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac rehabilitation attendance	Measured as 'self-reported CR attendance'	24 weeks
Secondary	Change in Health-related Quality of Life	Measured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'. Min. score: 0, max score: 42. Higher scores indicating a better outcome.	Baseline to 24 weeks
Secondary	Change in Self-efficacy	Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome	Baseline to 24 weeks
Secondary	Change in symptoms of anxiety and depression	Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome	Baseline to 24 weeks
Secondary	Change in dietary quality	Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome	Baseline to 24 weeks
Secondary	Change in physical activity	Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome	Baseline to 24 weeks
Secondary	Qualitative content of disease trajectory	Semi-structured qualitative interviews with patients (n=20-25)	Baseline to 24 weeks