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

August 26, 2024 updated by: Defactum, Central Denmark Region

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus Municipality
      • Ringkøbing, Denmark
        • Ringkøbing-Skjern Municipality
      • Viborg, Denmark
        • Viborg Municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • age < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Six months
Evaluate the CR teams' view on the programme
Six months
Mechanisms of impact
Time Frame: Six months
Evaluate how the CR teams respond to and interact with the programme
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Defactum, Central Denmark Region

Collaborators

University of Aarhus
Aarhus Municipality, Denmark
Viborg Municipality, Denmark
Ringkøbing-Skjern municipality, Denmark

Investigators

  • Principal Investigator: Charlotte Ibsen, PhD, Defactum, Central Denmark Region
  • Study Chair: Thomas Maribo, PhD, Defactum, Central Denmark Region and Aarhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Heart Priority Programme

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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