The Heart Priority Programme for Patients at Risk of Dropout From Cardiac Rehabilitation - a Development- and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
- 试验地点
- 4
- 主要终点
- Implementation (reach and fidelity)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •age < 18
结局指标
主要结局
Implementation (reach and fidelity)
时间窗: 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)
次要结局
- Acceptability(Six months)
- Mechanisms of impact(Six months)