The Heart Priority Programme for Cardiac Patients at Risk of Dropout From Cardiac Rehabilitation
NCT ID: NCT06575764
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
260 participants
INTERVENTIONAL
2023-01-08
2025-01-31
Brief Summary
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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.
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Detailed Description
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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:
1. 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)
2. Systematically communicating patient information to colleagues in the CR team
3. 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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Heart priority Programme
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
The Heart Priority Programme
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
Interventions
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The Heart Priority Programme
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Aarhus Municipality, Denmark
OTHER
Viborg Municipality, Denmark
UNKNOWN
Ringkøbing-Skjern municipality, Denmark
UNKNOWN
Defactum, Central Denmark Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Charlotte Ibsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Defactum, Central Denmark Region
Thomas Maribo, PhD
Role: STUDY_CHAIR
Defactum, Central Denmark Region and Aarhus University
Locations
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Aarhus Municipality
Aarhus, , Denmark
Ringkøbing-Skjern Municipality
Ringkøbing, , Denmark
Viborg Municipality
Viborg, , Denmark
Countries
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References
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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.
Cowie 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.
Dibben 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.
Santiago 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.
Turk-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.
Resurreccion 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.
Skivington 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.
Hawkins 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.
Moore 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.
O'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.
Hoffmann 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.
Ibsen 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.
Related Links
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Danish Health Authority. National Clinical Guideline On Cardiac Rehabilitation, 2015
Other Identifiers
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The Heart Priority Programme
Identifier Type: -
Identifier Source: org_study_id
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