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Ischemic Heart DiseaseNCT04945486

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

A study testing Peer-mentor intervention in people with Ischemic Heart Disease, run by University College Copenhagen at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Ischemic Heart Disease
What is being tested?
Peer-mentor intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
2 sitesDenmark
Study dates
2 Aug 2021to 25 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • Patients unable to provide written consent

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites
  • Nordsjællands Hospital - Frederikssund

    Frederikssund

  • Nordsjællands Hospital - Hillerød

    Hillerød

Other trials in Denmark

About this study

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

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.

Read more

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.

Being tested
Peer-mentor intervention
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer-mentor interventionOther

    Peer-mentor support for up to 6 months

Study groups in NCT04945486
Study groupRoleWhat they receive
Peer-mentoringExperimentalThe patients (mentees) are matched with a peer-mentor i.e. a person with a similar life situation or health problem as one self
Receives: Other: Peer-mentor intervention
Usual careNo interventionUsual care provided by professional healthcare workers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac rehabilitation attendance

    Measured as 'self-reported CR attendance'

    Measured: 24 weeks

Secondary outcomes (6)
  1. 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.

    Measured: Baseline to 24 weeks

  2. Change in Self-efficacy

    Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome

    Measured: Baseline to 24 weeks

  3. 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

    Measured: Baseline to 24 weeks

  4. Change in dietary quality

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

    Measured: Baseline to 24 weeks

  5. Change in physical activity

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

    Measured: Baseline to 24 weeks

  6. Qualitative content of disease trajectory

    Semi-structured qualitative interviews with patients (n=20-25)

    Measured: Baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start2 Aug 2021
  3. Primary completion25 Aug 2023
  4. Study completion25 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945486
Sponsor's protocol ID
Alias: 200348 RCT
Status last verified
Sep 2023
First submitted
22 Jun 2021
Last updated
15 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pedersen M, Petersen RA, Boateng T, Egerod I, Overgaard D, Bennich BB. Peer-Mentor Support for Older, Vulnerable Patients With Ischemic Heart Disease: A Mixed Methods Process-Outcome Evaluation. J Adv Nurs. 2025 Dec;81(12):8946-8958. doi: 10.1111/jan.16899. Epub 2025 Mar 17.

    PubMed 40095257

Questions about this trial

What is this clinical trial studying?

A study testing Peer-mentor intervention in people with Ischemic Heart Disease, run by University College Copenhagen at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac rehabilitation attendance (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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