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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575764 on ClinicalTrials.gov