The Effect of Peer-mentor Support for Older Vulnerable Patients With Ischemic Heart Disease
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Peer-mentor intervention
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Heart Disease
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
Sites / Locations
- Nordsjællands Hospital - Frederikssund
- Nordsjællands Hospital - Hillerød
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Peer-mentoring
Usual care
Arm Description
The patients (mentees) are matched with a peer-mentor i.e. a person with a similar life situation or health problem as one self
Usual care provided by professional healthcare workers
Outcomes
Primary Outcome Measures
Cardiac rehabilitation attendance
Measured as 'self-reported CR attendance'
Secondary Outcome Measures
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.
Change in Self-efficacy
Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome
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
Change in dietary quality
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Change in physical activity
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Qualitative content of disease trajectory
Semi-structured qualitative interviews with patients (n=20-25)
Full Information
NCT ID
NCT04945486
First Posted
June 22, 2021
Last Updated
September 14, 2023
Sponsor
University College Copenhagen
Collaborators
Nordsjællands Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04945486
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
August 25, 2023 (Actual)
Study Completion Date
August 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Copenhagen
Collaborators
Nordsjællands Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Masking is not possible
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer-mentoring
Arm Type
Experimental
Arm Description
The patients (mentees) are matched with a peer-mentor i.e. a person with a similar life situation or health problem as one self
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care provided by professional healthcare workers
Intervention Type
Other
Intervention Name(s)
Peer-mentor intervention
Intervention Description
Peer-mentor support for up to 6 months
Primary Outcome Measure Information:
Title
Cardiac rehabilitation attendance
Description
Measured as 'self-reported CR attendance'
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Health-related Quality of Life
Description
Measured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'. Min. score: 0, max score: 42. Higher scores indicating a better outcome.
Time Frame
Baseline to 24 weeks
Title
Change in Self-efficacy
Description
Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome
Time Frame
Baseline to 24 weeks
Title
Change in symptoms of anxiety and depression
Description
Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome
Time Frame
Baseline to 24 weeks
Title
Change in dietary quality
Description
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Time Frame
Baseline to 24 weeks
Title
Change in physical activity
Description
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Time Frame
Baseline to 24 weeks
Title
Qualitative content of disease trajectory
Description
Semi-structured qualitative interviews with patients (n=20-25)
Time Frame
Baseline to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nordsjællands Hospital - Frederikssund
City
Frederikssund
Country
Denmark
Facility Name
Nordsjællands Hospital - Hillerød
City
Hillerød
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Peer-mentor Support for Older Vulnerable Patients With Ischemic Heart Disease
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