Clinical trial NCT04945486: The Effect of Peer-mentor Support for Older Vulnerable Patients With Ischemic Heart Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: University College Copenhagen
Sponsor class: OTHER
Collaborators: name: Nordsjællands Hospital
First posted: 2021-06-30
Enrollment: 117
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cardiac rehabilitation attendance
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Health-related Quality of Life
timeFrame: Baseline to 24 weeks
measure: Change in Self-efficacy
timeFrame: Baseline to 24 weeks
measure: Change in symptoms of anxiety and depression
timeFrame: Baseline to 24 weeks
measure: Change in dietary quality
timeFrame: Baseline to 24 weeks
measure: Change in physical activity
timeFrame: Baseline to 24 weeks
measure: Qualitative content of disease trajectory
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: Frederikssund
country: Denmark
facility: Nordsjællands Hospital - Frederikssund
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital - Hillerød
Study officials:
References: