The Heart Priority Programme for Cardiac Patients at Risk of Dropout From Cardiac Rehabilitation
NCT06575764 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2024-08-28
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
Interventions
- OTHER
-
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
Sponsors & Collaborators
-
University of Aarhus
collaborator OTHER -
Aarhus Municipality, Denmark
collaborator OTHER -
Viborg Municipality, Denmark
collaborator UNKNOWN -
Ringkøbing-Skjern municipality, Denmark
collaborator UNKNOWN -
Defactum, Central Denmark Region
lead OTHER_GOV
Principal Investigators
-
Charlotte Ibsen, PhD · Defactum, Central Denmark Region
-
Thomas Maribo, PhD · Defactum, Central Denmark Region and Aarhus University
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-08
- Primary Completion
- 2025-01-31
- Completion
- 2025-01-31
Countries
- Denmark
Study Locations
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