Digital Transformation in the Implementation of Socially Differentiated and Patient-Centered Health Care After Heart Transplantation: The mHTX APP Program
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary outcome is reduced hospitalization
研究概览
简要总结
Current Danish studies emphasize the importance of better integrated and efficient lifelong health care to heart-transplant recipients regardless of socioeconomic position. Our objective is to design and evaluate a new digital patient-centered and socially differentiated program after heart transplantation in Denmark. Investigators use a participatory approach with involvement of users: 1) Design phase: Mobile health app; Patient-reported outcomes; Case manager function, 2) Feasibility Study with 25 recipients and process evaluation within 1 month, 3) Randomized Study, including 200 recipients followed for 1 year. Effectiveness is measured as cross-sectional care utilization; costs; events. Efficacy is measured as adherence to pharmacotherapies, labor market participation, and quality of care. Nationwide registers will be linked with interview data, surveys, and app login. This digital transformation of cross-sectional care after heart transplantation will facilitate equality in health.
详细描述
BACKGROUND The International Society for Heart and Lung Transplantation recommends that transplant centers establish long-term follow-up through multidisciplinary and cross-sectional management programs after heart transplantation (HTX). Our Danish studies in heart-transplant recipients have documented that socioeconomic disadvantages and multimorbidity lead to higher utilization of cross-sectional health care services, poorer long-term prognosis, a higher prevalence of non-adherence to recommended pharmacotherapies and reduced labor market participation. Heart-transplant recipients and relatives report that health care services are insufficiently patient-centered and poorly coordinated. Existing studies in heart-transplant recipients clearly demonstrate the need for more socially differentiated and patient-centered health care management after surgery. Moreover, the studies emphasize the importance of better integrated and efficient health care to Danish heart-transplant recipients regardless of socioeconomic position (SEP).
OBJECTIVE AND HYPOTHESIS The main objective of the project is to design and evaluate the effectiveness and efficacy of a new patient-centered and socially differentiated mobile health application program in a Danish setting with usual recommended long-term multidisciplinary and cross-sectional management after HTX (the mHTX APP Program). This program will combine current evidence and theoretical strategies in the holistic Chronic Care Model (CCM). Moreover, investigators will follow the Medical Research Council Guidance to design and evaluate multicomponent interventions by meaningful involvement of heart-transplant recipients, relatives, and health care professionals.
The overall hypothesis is that the mHTX APP Program will interact with and contribute to effectiveness: 1) reduce cross-sectional health care utilizations, 2) reduce health care costs, 3) reduce adverse events), and efficacy: 4) improve adherence to recommended pharmacotherapies, 5) increase labor market participation, and 6) improve perceived quality of chronic illness care.
SIGNIFICANCE AND CLINICAL IMPLICATIONS The Danish health care system is characterized by free access and universal coverage. Despite this, inequity in health care services for heart-transplant recipients emphasizes the need for a more equitable management of socioeconomic determinants and multimorbidity. A national participatory research program on heart-transplant recipients with a patient-centered and socially differentiated eHealth approach will promote higher equity and social awareness in resource allocation. Digital management in clinical practice offers connectivity and reel-time patient-level information, allowing health care professionals to identify concerns and risks earlier before they lead to unnecessary concerns and adverse outcomes. Therefore, the mHTx APP Program may transform cross-sectional services after HTX and reduce of inequality in life-long health care. Moreover, the Danish health care system is financially challenged, and there is an urgent need to evaluate alternative pathways in mHealth follow-up in collaboration between the highly specialized heart-transplant centers and the primary health care system.
Socioeconomic inequality in health care services has been documented in Danish patients with chronic heart failure. Our innovative set-up combining mHealth with the chronic care strategies for case managers will directly impact on structural causes of disparity to improve equity in cross-sectional and life-long care for other groups with chronic diseases such as the heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Recipients are eligible if they are ≥18 years and not terminal.
排除标准
- •Recipients who do not own and use an Android or Apple smartphone or are unable to understand Danish will be excluded.
研究组 & 干预措施
Control group:
Usual care with recommended long-term multidisciplinary and cross-sectional management after HTX (n=100).
Intervention group
The new and feasible mHTx APP Program in the setting of usual recommended long-term multidisciplinary and cross-sectional management after HTX (n=100)
干预措施: Intervention (Behavioral)
结局指标
主要结局
The primary outcome is reduced hospitalization
时间窗: Within one year after index date
From the Danish National Patient Registry (DNPR), investigators will obtain information on total in-hospital activity (all admissions and outpatient dates) and sum up.
次要结局
- Medical therapies(Within one year after index date)
- General practice activity(Within one year after index date)
- Health care costs(Within one year after index date)
- Adverse events(Within one year after index date)
- Adherence to recommended pharmacotherapies(Within one year after index date)
- Adherence to immunosuppressive treatment(Within one year after index date)
- Labor market participation(Within one year after index date)
- Patient Assessment of Chronic Illness Care(Within one year after index date)
- Multimorbidity Treatment Burden(Within one year after index date)
- System Usability Scale(Within one year after index date)
