Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

Myocardial Infarction Clinical Trial

Official title:

'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507529
• Other study ID #: Alias: 200348
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: June 2021
• 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 myocardial infarction (MI) 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 ischemic heart disease. 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 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 feasibility and acceptability of methods used in a peer-mentor intervention among older female and vulnerable post MI patients.

DESIGN AND METHODS: The study is designed as a one arm feasibility study. Patients (n=20) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital. 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 MI patients; establishing the novelty of the current study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• =65 years and diagnosed with MI 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

• Infarction
• Myocardial Infarction

Intervention

Other:
• Peer-mentoring
Patients (mentees) are matched with a peer-mentor. Throughout the intervention period (24 weeks), the mentee and the mentor will have informal telephone contact and meet face-to face approximately 8 times during the intervention period.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University College Copenhagen	Danish Nurses Organisation, Nordsjællands Hospital, Velux Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number of patients included from eligible patients	Baseline
Primary	Dropout	Number of patients not completing the intervention	24 weeks
Primary	Satisfaction with intervention	Semi-structured qualitative interviews with patients	12 weeks
Primary	Number of contacts	Number of contacts between patient and peer-mentor	24 weeks
Primary	Content of contacts	Content of contacts between patient and peer-mentor will be assessed through open ended question on questionnaire i.e. 'What was the content of your meeting? e.g face-to-face meeting with conversation about everyday life'	24 weeks
Primary	CR attendance	Measured as 'self-reported CR attendance'	12 weeks
Primary	CR attendance	Measured as 'self-reported CR attendance'	24 weeks
Primary	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
Primary	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
Primary	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
Primary	Change in dietary quality	Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome	Baseline to 24 weeks
Primary	Change in physical activity	Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome	Baseline to 24 weeks