Acute Coronary SyndromeNCT06575764
The Heart Priority Programme for Cardiac Patients at Risk of Dropout From Cardiac Rehabilitation
A study testing The Heart Priority Programme in people with Acute Coronary Syndrome, run by Defactum, Central Denmark Region at 3 sites in Denmark.
Trial summary
The goal of this study is to develop The Heart Priority programme, a supplement to standardised cardiac rehabilitation (CR) aimed at identifying and supporting cardiac patients at risk of dropout due to being in a vulnerable situation. Additionally, the study aims to test the programme through a feasibility study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- The Heart Priority Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 3 sitesDenmark
- Study dates
- 8 Jan 2023to 31 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute coronary syndrome
- age >18 years
- patients referred to CR in community healthcare services
- patients living in Central Denmark Region
- patients at risk of dropout due to being in a vulnerable situation.
Who cannot join
- age < 18
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus Municipality
Aarhus, 8000
Ringkøbing-Skjern Municipality
Ringkøbing
Viborg Municipality
Viborg
About this study
Official title: The Heart Priority Programme for Patients at Risk of Dropout From Cardiac Rehabilitation - a Development- and Feasibility Study
The goal of this study is to develop The Heart Priority programme, a supplement to standardised cardiac rehabilitation (CR) aimed at identifying and supporting cardiac patients at risk of dropout due to being in a vulnerable situation. Additionally, the study aims to test the programme through a feasibility study.
The programme comprises two main parts: 1) an evidence-based identification form to identify patients at risk of dropout from CR due to being in a vulnerable situation and 2) an add-on intervention targeted these patients.
Read more
The study will be guided by the Medical Research Council's framework for developing and evaluating complex interventions (MRC). The development follows an iterative three-stage process guided by the framework for co-producing and prototyping of healthcare interventions. Stage 1 is preparation by considering the knowledgebase. Building on this knowledge, stage 2 and 3 includes a co-production and prototyping process, aiming to develop, field test and adapt the programme, deemed ready for feasibility testing.
The feasibility study will be designed as a single-arm follow-up study conducted in two community health care centres in Denmark. Process data will be collected continuously over a six-months period and at the study's conclusion, focussing on three dimensions: implementation (reach and fidelity), acceptability, and mechanism of impact.
Read the detailed description
Despite advancements in reducing cardiovascular disease, heart disease remains a significant health issue. Cardiac rehabilitation (CR) is crucial for recovery, with evidence showing its positive impact on morbidity, mortality, and functioning. However, dropout rates, especially among patients in a vulnerable situation, are high due to social inequalities and lack of tailored interventions. To implement interventions for individuals in a vulnerable situation, it is necessary to: 1) identify the target group and 2) develop an intervention tailored to the group. There is currently no such intervention within the field of CR. Therefore, we developed, and feasibility tested the Heart Priority Programme aiming to reduce dropouts in cardiac rehabilitation among patients in a vulnerable situation.
The purpose is to develop the Heart Priority Programme in close collaboration with stakeholders and subsequently conduct a feasibility study in community healthcare services within the Central Denmark Region.
The study follows the Medical Research Council's framework for developing complex interventions, focusing on the development and feasibility phases.
First a development study will be conducted. The development of the Heart Priority Programme will follow a three-stage iterative process, including evidence review, stakeholder consultations, co-production of intervention content, and prototyping involving close collaboration between cardiac patients, healthcare professionals, and researchers. The Heart Priority Programme encompasses two main parts: 1) an evidence-based identification form to identify patients being in a vulnerable situation (professional tool to be used during the initial consultation) and 2) an add-on intervention to supplement standard CR targeted these patients.
Subsequently, a feasibility study designed as a single-arm follow-up study will be conducted in two community healthcare services in Central Denmark Region. The programme is delivered by the CR team. The evidence-based identification form will be used for all cardiac patients referred to CR and fulfilled during the initial consultation. If the healthcare professional identifies a patient at risk of dropout due to being in a vulnerable situation this patient will receive the add-on intervention targeted these patients. The add-on intervention encompasses three core elements:
- Assigning a contact person with specific responsibilities (e.g., ensure the patient feels safe and welcome at the first session, and acting as a contact in case of cancellation)
- Systematically communicating patient information to colleagues in the CR team
- Systematic follow-up (e.g., maintaining continuous contact in case of cancellation/absence, and ongoing follow-up).
The add-intervention will be described in detailed in accordance with the Template for Intervention Description and Replication (TIDieR)
Both quantitative (data from the identification form) and qualitative methods (data from feedback meetings with healthcare professionals) will be used to collect data. Process data will be collected continuously over a six-months period and at the study's conclusion, focussing on three dimensions: implementation (reach and fidelity), acceptability, and mechanism of impact. Descriptive statistics will be used to analyse implementation data, while content-driven analysis will be applied to assess acceptability and mechanisms of impact. Based on clinical and research judgment, a convenience sample of at least 150 cardiac patients referred to CR was deemed sufficient to adequately represent the target population and provide data for the feasibility study.
According to Danish legislation and the Act on Biomedical Research Ethics Committee System in Denmark, research without human biological material does not require approval from an ethics committee (§14 Section 2). The study was registered and approved by the Data Protection Agency of Central Denmark Region (1-16-02-121-24). Cardiac patients and healthcare professionals provide written informed consent to participate in the co-production process, like participants in the feasibility test.
If the feasibility study yields promising results, a larger-scale study will be conducted to evaluate the Heart Priority Programme's overall impact on dropout rates in cardiac rehabilitation.
- Conditions
- Acute Coronary Syndrome
- Being tested
- The Heart Priority Programme
- Keywords
- Cardiac Rehabilitation, Complex intervention, Co-production, Intervention development, Feasibility study, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Heart Priority ProgrammeOther
The programme is delivered by the Cardiac Rehabilitation (CR) team. It consist of two main parts: 1) an evidence-based identification form to identify patients at risk of dropout due to being in a vulnerable situation and 2) an add-on intervention to standard CR targeted these patients. The add-on intervention encompasses three core elements: 1) Assigning a contact person with specific responsibilities, 2) Systematically communicating patient information to colleagues in the CR team and 3) Systematic follow-up
| Study group | Role | What they receive |
|---|---|---|
| Heart priority Programme | Experimental | The Heart Priority Programme was developed to supplement standardised cardiac rehabilitation to reduce dropouts among cardiac patients at risk of dropout due to being in a vulnerable situation Receives: Other: The Heart Priority Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation (reach and fidelity)
Evaluate: 1)The extent to which the target group encounters the programme (reach) and 2) Whether the programme was delivered as intended (fidelity)
Measured: Six months
Secondary outcomes (2)
Acceptability
Evaluate the CR teams' view on the programme
Measured: Six months
Mechanisms of impact
Evaluate how the CR teams respond to and interact with the programme
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start8 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defactum, Central Denmark Region
- Sponsor type
- Other government
- Collaborators
- University of Aarhus, Aarhus Municipality, Denmark, Viborg Municipality, Denmark, Ringkøbing-Skjern municipality, Denmark
- Responsible party
- Sponsor
- Investigators
- Charlotte Ibsen, PhD, Principal investigator, Defactum, Central Denmark RegionThomas Maribo, PhD, Study chair, Defactum, Central Denmark Region and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575764
- Sponsor's protocol ID
- The Heart Priority Programme
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur J Prev Cardiol. 2022 Feb 19;29(1):5-115. doi: 10.1093/eurjpc/zwab154. No abstract available.
PubMed 34558602Cowie A, Buckley J, Doherty P, Furze G, Hayward J, Hinton S, Jones J, Speck L, Dalal H, Mills J; British Association for Cardiovascular Prevention and Rehabilitation (BACPR). Standards and core components for cardiovascular disease prevention and rehabilitation. Heart. 2019 Apr;105(7):510-515. doi: 10.1136/heartjnl-2018-314206. Epub 2019 Jan 30.
PubMed 30700518Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
PubMed 34741536Santiago de Araujo Pio C, Chaves GS, Davies P, Taylor RS, Grace SL. Interventions to promote patient utilisation of cardiac rehabilitation. Cochrane Database Syst Rev. 2019 Feb 1;2(2):CD007131. doi: 10.1002/14651858.CD007131.pub4.
PubMed 30706942Turk-Adawi KI, Grace SL. Narrative review comparing the benefits of and participation in cardiac rehabilitation in high-, middle- and low-income countries. Heart Lung Circ. 2015 May;24(5):510-20. doi: 10.1016/j.hlc.2014.11.013. Epub 2014 Nov 29.
PubMed 25534902Resurreccion DM, Motrico E, Rigabert A, Rubio-Valera M, Conejo-Ceron S, Pastor L, Moreno-Peral P. Barriers for Nonparticipation and Dropout of Women in Cardiac Rehabilitation Programs: A Systematic Review. J Womens Health (Larchmt). 2017 Aug;26(8):849-859. doi: 10.1089/jwh.2016.6249. Epub 2017 Apr 7.
PubMed 28388314Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Hawkins J, Madden K, Fletcher A, Midgley L, Grant A, Cox G, Moore L, Campbell R, Murphy S, Bonell C, White J. Development of a framework for the co-production and prototyping of public health interventions. BMC Public Health. 2017 Sep 4;17(1):689. doi: 10.1186/s12889-017-4695-8.
PubMed 28870192Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
PubMed 25791983O'Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, Jansen YJ, Mills N, Moore G, Donovan JL. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015 Sep 7;1:32. doi: 10.1186/s40814-015-0026-y. eCollection 2015.
PubMed 27965810Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.
PubMed 24609605Ibsen C, Katholm KK, Jakobsen A, Eriksen GB, Lysdal L, Nielsen UK, Ravn MB, Maribo T. Reducing dropout rates in cardiac rehabilitation among cardiac patients in a vulnerable situation: systematic development and feasibility testing of the Heart Priority Programme. BMC Health Serv Res. 2024 Dec 18;24(1):1579. doi: 10.1186/s12913-024-12073-x.
PubMed 39695726
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heart Priority Programme for Patients at Risk of Dropout From Cardiac Rehabilitation - a Development- and Feasibility Study
- ClinicalTrials.gov ID
- NCT06575764
- Acronym / sponsor ID
- The Heart Priority Programme
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiac Rehabilitation, Complex intervention, Co-production, Intervention development, Feasibility study, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Defactum, Central Denmark RegionOther government
- Collaborators
- University of Aarhus, Aarhus Municipality, Denmark, Viborg Municipality, Denmark, Ringkøbing-Skjern municipality, Denmark
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 28 Aug 2024 (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.
The goal of this study is to develop The Heart Priority programme, a supplement to standardised cardiac rehabilitation (CR) aimed at identifying and supporting cardiac patients at risk of dropout due to being in a vulnerable situation. Additionally, the study aims to test the programme through a feasibility study.
The programme comprises two main parts: 1) an evidence-based identification form to identify patients at risk of dropout from CR due to being in a vulnerable situation and 2) an add-on intervention targeted these patients.
The study will be guided by the Medical Research Council's framework for developing and evaluating complex interventions (MRC). The development follows an iterative three-stage process guided by the framework for co-producing and prototyping of healthcare interventions. Stage 1 is preparation by considering the knowledgebase. Building on this knowledge, stage 2 and 3 includes a co-production and prototyping process, aiming to develop, field test and adapt the programme, deemed ready for feasibility testing.
The feasibility study will be designed as a single-arm follow-up study conducted in two community health care centres in Denmark. Process data will be collected continuously over a six-months period and at the study's conclusion, focussing on three dimensions: implementation (reach and fidelity), acceptability, and mechanism of impact.
Detailed description
Despite advancements in reducing cardiovascular disease, heart disease remains a significant health issue. Cardiac rehabilitation (CR) is crucial for recovery, with evidence showing its positive impact on morbidity, mortality, and functioning. However, dropout rates, especially among patients in a vulnerable situation, are high due to social inequalities and lack of tailored interventions. To implement interventions for individuals in a vulnerable situation, it is necessary to: 1) identify the target group and 2) develop an intervention tailored to the group. There is currently no such intervention within the field of CR. Therefore, we developed, and feasibility tested the Heart Priority Programme aiming to reduce dropouts in cardiac rehabilitation among patients in a vulnerable situation.
The purpose is to develop the Heart Priority Programme in close collaboration with stakeholders and subsequently conduct a feasibility study in community healthcare services within the Central Denmark Region.
The study follows the Medical Research Council's framework for developing complex interventions, focusing on the development and feasibility phases.
First a development study will be conducted. The development of the Heart Priority Programme will follow a three-stage iterative process, including evidence review, stakeholder consultations, co-production of intervention content, and prototyping involving close collaboration between cardiac patients, healthcare professionals, and researchers. The Heart Priority Programme encompasses two main parts: 1) an evidence-based identification form to identify patients being in a vulnerable situation (professional tool to be used during the initial consultation) and 2) an add-on intervention to supplement standard CR targeted these patients.
Subsequently, a feasibility study designed as a single-arm follow-up study will be conducted in two community healthcare services in Central Denmark Region. The programme is delivered by the CR team. The evidence-based identification form will be used for all cardiac patients referred to CR and fulfilled during the initial consultation. If the healthcare professional identifies a patient at risk of dropout due to being in a vulnerable situation this patient will receive the add-on intervention targeted these patients. The add-on intervention encompasses three core elements:
- Assigning a contact person with specific responsibilities (e.g., ensure the patient feels safe and welcome at the first session, and acting as a contact in case of cancellation)
- Systematically communicating patient information to colleagues in the CR team
- Systematic follow-up (e.g., maintaining continuous contact in case of cancellation/absence, and ongoing follow-up).
The add-intervention will be described in detailed in accordance with the Template for Intervention Description and Replication (TIDieR)
Both quantitative (data from the identification form) and qualitative methods (data from feedback meetings with healthcare professionals) will be used to collect data. Process data will be collected continuously over a six-months period and at the study's conclusion, focussing on three dimensions: implementation (reach and fidelity), acceptability, and mechanism of impact. Descriptive statistics will be used to analyse implementation data, while content-driven analysis will be applied to assess acceptability and mechanisms of impact. Based on clinical and research judgment, a convenience sample of at least 150 cardiac patients referred to CR was deemed sufficient to adequately represent the target population and provide data for the feasibility study.
According to Danish legislation and the Act on Biomedical Research Ethics Committee System in Denmark, research without human biological material does not require approval from an ethics committee (§14 Section 2). The study was registered and approved by the Data Protection Agency of Central Denmark Region (1-16-02-121-24). Cardiac patients and healthcare professionals provide written informed consent to participate in the co-production process, like participants in the feasibility test.
If the feasibility study yields promising results, a larger-scale study will be conducted to evaluate the Heart Priority Programme's overall impact on dropout rates in cardiac rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Heart priority Programme | Experimental | Other: The Heart Priority ProgrammeThe Heart Priority Programme was developed to supplement standardised cardiac rehabilitation to reduce dropouts among cardiac patients at risk of dropout due to being in a vulnerable situation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with acute coronary syndrome
- age >18 years
- patients referred to CR in community healthcare services
- patients living in Central Denmark Region
- patients at risk of dropout due to being in a vulnerable situation.
Key exclusion criteria (1 listed)
- age < 18
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 |
|---|---|---|
| The Heart Priority ProgrammeThe programme is delivered by the Cardiac Rehabilitation (CR) team. It consist of two main parts: 1) an evidence-based identification form to identify patients at risk of dropout due to being in a vulnerable situation and 2) an add-on intervention to standard CR targeted these patients. The add-on intervention encompasses three core elements: 1) Assigning a contact person with specific responsibilities, 2) Systematically communicating patient information to colleagues in the CR team and 3) Systematic follow-up | Other | Heart priority Programme |
Primary outcome
Implementation (reach and fidelity)
Time frame: Six months
Evaluate: 1)The extent to which the target group encounters the programme (reach) and 2) Whether the programme was delivered as intended (fidelity)
2 secondary outcomes
Acceptability
Time frame: Six months
Mechanisms of impact
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 34558602Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur J Prev Cardiol. 2022 Feb 19;29(1):5-115. doi: 10.1093/eurjpc/zwab154. No abstract available.
- Background: PubMed 30700518Cowie A, Buckley J, Doherty P, Furze G, Hayward J, Hinton S, Jones J, Speck L, Dalal H, Mills J; British Association for Cardiovascular Prevention and Rehabilitation (BACPR). Standards and core components for cardiovascular disease prevention and rehabilitation. Heart. 2019 Apr;105(7):510-515. doi: 10.1136/heartjnl-2018-314206. Epub 2019 Jan 30.
- Background: PubMed 34741536Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
- Background: PubMed 30706942Santiago de Araujo Pio C, Chaves GS, Davies P, Taylor RS, Grace SL. Interventions to promote patient utilisation of cardiac rehabilitation. Cochrane Database Syst Rev. 2019 Feb 1;2(2):CD007131. doi: 10.1002/14651858.CD007131.pub4.
- Background: PubMed 25534902Turk-Adawi KI, Grace SL. Narrative review comparing the benefits of and participation in cardiac rehabilitation in high-, middle- and low-income countries. Heart Lung Circ. 2015 May;24(5):510-20. doi: 10.1016/j.hlc.2014.11.013. Epub 2014 Nov 29.
- Background: PubMed 28388314Resurreccion DM, Motrico E, Rigabert A, Rubio-Valera M, Conejo-Ceron S, Pastor L, Moreno-Peral P. Barriers for Nonparticipation and Dropout of Women in Cardiac Rehabilitation Programs: A Systematic Review. J Womens Health (Larchmt). 2017 Aug;26(8):849-859. doi: 10.1089/jwh.2016.6249. Epub 2017 Apr 7.
- Background: PubMed 34593508Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Background: PubMed 28870192Hawkins J, Madden K, Fletcher A, Midgley L, Grant A, Cox G, Moore L, Campbell R, Murphy S, Bonell C, White J. Development of a framework for the co-production and prototyping of public health interventions. BMC Public Health. 2017 Sep 4;17(1):689. doi: 10.1186/s12889-017-4695-8.
- Background: PubMed 25791983Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
- Background: PubMed 27965810O'Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, Jansen YJ, Mills N, Moore G, Donovan JL. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015 Sep 7;1:32. doi: 10.1186/s40814-015-0026-y. eCollection 2015.
- Background: PubMed 24609605Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.
- Derived from this study: PubMed 39695726Ibsen C, Katholm KK, Jakobsen A, Eriksen GB, Lysdal L, Nielsen UK, Ravn MB, Maribo T. Reducing dropout rates in cardiac rehabilitation among cardiac patients in a vulnerable situation: systematic development and feasibility testing of the Heart Priority Programme. BMC Health Serv Res. 2024 Dec 18;24(1):1579. doi: 10.1186/s12913-024-12073-x.
- 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.
Charlotte Ibsen, PhD principal investigator
Defactum, Central Denmark Region
Thomas Maribo, PhD study chair
Defactum, Central Denmark Region and Aarhus University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Heart Priority Programme in people with Acute Coronary Syndrome, run by Defactum, Central Denmark Region at 3 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 5 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Implementation (reach and fidelity) (time frame: Six months). 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 NCT06575764, which also lists 12 linked publications.
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 28 Aug 2024.