Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575764
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
The Heart Priority Programme for Cardiac Patients at Risk of Dropout From Cardiac Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Heart Priority Programme for Patients at Risk of Dropout From Cardiac Rehabilitation - a Development- and Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Councils 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 studys conclusion focussing on three dimensions implementation reach and fidelity acceptability and mechanism of impact
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 Councils 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 studys conclusion focussing on three dimensions implementation reach and fidelity acceptability and mechanism of impact
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 Councils 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 eg 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 eg maintaining continuous contact in case of cancellationabsence 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 studys 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 Programmes overall impact on dropout rates in cardiac rehabilitation
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 Councils 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 eg 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 eg maintaining continuous contact in case of cancellationabsence 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 studys 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 Programmes overall impact on dropout rates in cardiac rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None