NCT04507529

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

August 5, 2020

Last Update Submit

June 22, 2021

Conditions

Outcome Measures

Primary Outcomes (12)

  • Recruitment

    Number of patients included from eligible patients

    Baseline

  • Dropout

    Number of patients not completing the intervention

    24 weeks

  • Satisfaction with intervention

    Semi-structured qualitative interviews with patients

    12 weeks

  • Number of contacts

    Number of contacts between patient and peer-mentor

    24 weeks

  • 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

  • CR attendance

    Measured as 'self-reported CR attendance'

    12 weeks

  • CR attendance

    Measured as 'self-reported CR attendance'

    24 weeks

  • 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

  • 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

  • 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

  • Change in dietary quality

    Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome

    Baseline to 24 weeks

  • Change in physical activity

    Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome

    Baseline to 24 weeks

Study Arms (1)

Peer-mentoring

EXPERIMENTAL

Peer-mentoring

Other: Peer-mentoring

Interventions

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.

Peer-mentoring

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥65 years and diagnosed with MI and referred to CR and female or low SEP or single living or non-western background.

You may not qualify if:

  • Patients unable to provide written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nordsjællands Hospital - Frederikssund

Frederikssund, 3600, Denmark

Location

Nordsjællands Hospital - Hillerød

Hillerød, 3400, Denmark

Location

Related Publications (1)

  • Pedersen M, Bennich B, Boateng T, Beck AM, Sibilitz K, Andersen I, Overgaard D. Peer-mentor support for older vulnerable myocardial infarction patients referred to cardiac rehabilitation: single-arm feasibility study. Pilot Feasibility Stud. 2022 Aug 9;8(1):172. doi: 10.1186/s40814-022-01141-w.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Maria K Pedersen, Ph.d.

    University College Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 11, 2020

Study Start

September 7, 2020

Primary Completion

June 21, 2021

Study Completion

June 21, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations