Institute for Health and Behaviour - Research Unit INSIDE, Universite du Luxembourg, Esch-sur-Alzette, Luxembourg.
College of Medicine and Health Sciences, University of Rwanda, Butare, Rwanda.
BMJ Open. 2019 Jul 24;9(7):e028427. doi: 10.1136/bmjopen-2018-028427.
In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients' health behaviours and HBCPs' work satisfaction.
This is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs' programme; (2) HBCPs' programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs' programme. Under each hospital, administrative areas implementing the HBCPs' programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs' programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.
Ethics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.
NCT03376607; Pre-results.
在卢旺达，糖尿病的患病率估计在 3.1%至 4.3%之间。为了解决非传染性疾病和卫生人力资源短缺的问题，卢旺达卫生部推出了家庭保健从业者（HBCP）计划：经过六个月的培训，非专业人员为慢性病患者提供长期护理。利用移动技术解决方案也有助于改善健康和医疗保健。D²卢旺达研究旨在：（a）确定在卢旺达管理糖尿病的综合方案的疗效，该方案将通过 HBCP 每月对患者进行评估，并提供教育和自我管理的移动健康患者工具；（b）从定性角度探讨干预措施的实施方式、面临的挑战和效果，以及患者健康行为和 HBCP 工作满意度的变化。
这是一项混合方法序贯解释性研究。首先，将进行为期一年的群组随机对照试验，包括两项干预措施（1）HBCP 计划；（2）HBCP 计划+移动健康应用）和常规护理（对照组）。目前，有九家医院开展了 HBCP 计划。在每家医院下，实施 HBCP 计划的行政区域将被随机分配接受干预 1 或 2。每个区域的合格患者将接受相同的干预。没有 HBCP 计划的区域将被分配到对照组。主要结局将是糖化血红蛋白的变化。次要结局包括药物依从性、死亡率、并发症、健康相关生活质量、糖尿病相关困扰和健康素养。其次，在试验结束时，将与患者和 HBCP 进行焦点小组讨论。该研究得到了 Karen Elise Jensens 基金会、奥胡斯大学和卢森堡大学的支持。
该研究已获得卢旺达国家伦理委员会和卢森堡大学伦理审查小组的批准。研究结果将通过同行评议的出版物和会议报告进行传播。
NCT03376607；预结果。
