The Heart Priority Programme for Cardiac Patients at Risk of Dropout From Cardiac Rehabilitation

NCT06575764 | Active Not Recruiting DMC

• 1 other identifier: The Heart Priority Programme
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Acute Coronary Syndrome

Keywords

Cardiac Rehabilitation; Complex intervention; Co-production; Intervention development; Feasibility study; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

  Six months

Secondary Outcomes (2)

• Acceptability

  Six months

• Mechanisms of impact

  Six months

Study Arms (1)

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

Other: The Heart Priority Programme

Interventions

The Heart Priority Programme OTHER

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

Heart priority Programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• age \< 18

Sponsors & Collaborators

• Defactum, Central Denmark Region: lead
• University of Aarhus: collaborator
• Aarhus Municipality, Denmark: collaborator
• Viborg Municipality, Denmark: collaborator
• Ringkøbing-Skjern municipality, Denmark: collaborator

Study Sites (3)

Aarhus Municipality

Aarhus, 8000, Denmark

Location

Ringkøbing-Skjern Municipality

Ringkøbing, Denmark

Location

Viborg Municipality

Viborg, Denmark

Location

Related Publications (12)

• 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.

  PMID: 34558602 BACKGROUND

• 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.

  PMID: 30700518 BACKGROUND

• 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.

  PMID: 34741536 BACKGROUND

• 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.

  PMID: 30706942 BACKGROUND

• 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.

  PMID: 25534902 BACKGROUND

• 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.

  PMID: 28388314 BACKGROUND

• 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.

  PMID: 34593508 BACKGROUND

• 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.

  PMID: 28870192 BACKGROUND

• 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.

  PMID: 25791983 BACKGROUND

• 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.

  PMID: 27965810 BACKGROUND

• 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.

  PMID: 24609605 BACKGROUND

• 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.

  PMID: 39695726 DERIVED

Related Links

• Danish Health Authority. National Clinical Guideline On Cardiac Rehabilitation, 2015

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Charlotte Ibsen, PhD

  Defactum, Central Denmark Region

  PRINCIPAL INVESTIGATOR

• Thomas Maribo, PhD

  Defactum, Central Denmark Region and Aarhus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: January 8, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)