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.
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
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.
- Conditions
- Ischemic Heart Disease
- 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 group | Role | What they receive |
|---|---|---|
| Peer-mentoring | Experimental | The 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 care | No intervention | Usual care provided by professional healthcare workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac rehabilitation attendance
Measured as 'self-reported CR attendance'
Measured: 24 weeks
Secondary outcomes (6)
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
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
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
Change in dietary quality
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Measured: Baseline to 24 weeks
Change in physical activity
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Measured: Baseline to 24 weeks
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.
- First posted30 Jun 2021
- Study start2 Aug 2021
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University College Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsjaellands Hospital
- Responsible party
- Principal investigator, Maria Kjøller Pedersen, University College Copenhagen
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04945486
- Acronym / sponsor ID
- Alias: 200348 RCT
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University College CopenhagenUniversity, hospital or other
- Collaborators
- Nordsjaellands Hospital
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-mentoring | Experimental | Other: Peer-mentor interventionThe 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 | No intervention | –Usual care provided by professional healthcare workers |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- ≥65 years and diagnosed with IHD and referred to CR and female or low SEP or single living or non-western background
Key exclusion criteria (1 listed)
- Patients unable to provide written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-mentor interventionPeer-mentor support for up to 6 months | Other | Peer-mentoring |
Primary outcome
Cardiac rehabilitation attendance
Time frame: 24 weeks
Measured as 'self-reported CR attendance'
6 secondary outcomes
Change in Health-related Quality of Life
Time frame: Baseline to 24 weeks
Change in Self-efficacy
Time frame: Baseline to 24 weeks
Change in symptoms of anxiety and depression
Time frame: Baseline to 24 weeks
Change in dietary quality
Time frame: Baseline to 24 weeks
Change in physical activity
Time frame: Baseline to 24 weeks
Qualitative content of disease trajectory
Time frame: Baseline to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 40095257Pedersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.