Myocardial InfarctionNCT04507529
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients
A study testing Peer-mentoring in people with Myocardial Infarction, 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 myocardial infarction (MI) 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
- Myocardial Infarction
- What is being tested?
- Peer-mentoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 7 Sep 2020to 21 Jun 2021
- 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 MI 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, 3600
Nordsjællands Hospital - Hillerød
Hillerød, 3400
About this study
Official title: 'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution
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.
- Conditions
- Myocardial Infarction
- Being tested
- Peer-mentoring
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-mentoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-mentoring | Experimental | Peer-mentoring Receives: Other: Peer-mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of patients included from eligible patients
Measured: Baseline
Dropout
Number of patients not completing the intervention
Measured: 24 weeks
Satisfaction with intervention
Semi-structured qualitative interviews with patients
Measured: 12 weeks
Number of contacts
Number of contacts between patient and peer-mentor
Measured: 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'
Measured: 24 weeks
CR attendance
Measured as 'self-reported CR attendance'
Measured: 12 weeks
CR attendance
Measured as 'self-reported CR attendance'
Measured: 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.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start7 Sep 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
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 Myocardial InfarctionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, Danish Nurses Organisation, Nordsjaellands Hospital
- Responsible party
- Principal investigator, Maria Kjøller Pedersen, University College Copenhagen
- Investigators
- Maria K Pedersen, Ph.d., Principal investigator, University College Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507529
- Sponsor's protocol ID
- Alias: 200348
- Status last verified
- Jun 2021
- First submitted
- 5 Aug 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35945611
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution
- ClinicalTrials.gov ID
- NCT04507529
- Acronym / sponsor ID
- Alias: 200348
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College CopenhagenUniversity, hospital or other
- Collaborators
- Velux Fonden, Danish Nurses Organisation, Nordsjaellands Hospital
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 11 Aug 2020 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer-mentoring | Experimental | Other: Peer-mentoringPeer-mentoring |
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 MI 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-mentoringPatients (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. | Other | Peer-mentoring |
Primary outcome
Recruitment
Time frame: Baseline
Number of patients included from eligible patients
Dropout
Time frame: 24 weeks
Number of patients not completing the intervention
Satisfaction with intervention
Time frame: 12 weeks
Semi-structured qualitative interviews with patients
Number of contacts
Time frame: 24 weeks
Number of contacts between patient and peer-mentor
Content of contacts
Time frame: 24 weeks
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'
CR attendance
Time frame: 12 weeks
Measured as 'self-reported CR attendance'
CR attendance
Time frame: 24 weeks
Measured as 'self-reported CR attendance'
Change in Health-related Quality of Life
Time frame: Baseline to 24 weeks
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
Time frame: Baseline to 24 weeks
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
Time frame: Baseline to 24 weeks
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
Time frame: Baseline to 24 weeks
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
Change in physical activity
Time frame: Baseline to 24 weeks
Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
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 24 Jun 2021.
- Derived from this study: PubMed 35945611Pedersen 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.
- 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.
Maria K Pedersen, Ph.d. principal investigator
University College Copenhagen
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-mentoring in people with Myocardial Infarction, 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 24 Jun 2021. 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?
Recruitment (time frame: Baseline). The study lists 12 primary outcomes in all. 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 NCT04507529, 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 24 Jun 2021.