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临床试验/NCT03376607
NCT03376607Unknown不适用

Community- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda: The D²Rwanda Study

University of Aarhus9 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2019年1月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
209
试验地点
9
主要终点
Change in HbA1c

研究概览

简要总结

The Home Based Care Practitioners (HBCPs) programme has been established by the Rwandan Ministry of Health in response to the shortage of health professionals. Currently in its pilot first phase, it entails laypeople providing longitudinal care to chronic patients after receiving a six-month training.The diabetes mellitus (DM) prevalence in Rwanda is estimated at 3.5%. Technological mobile solutions can improve care by enabling patients to self-manage their disease.

It is hypothesised that the establishment of the HBCP programme with regular monthly assessments of DM patients and disease management by the programme's HBCPs improves the patients' HbA1c levels, medication adherence, health-related quality of life, mental well-being, and health literacy levels. It is also hypothesised that patients will show further improvement when the HBCP programme is coupled with a mobile health application for patients that includes diaries, notifications and educational material. The aim of the study is to determine the efficacy of such an integrated programme for the management of DM in primary health care in Rwanda.

Study design: The study is designed as a one-year, open-label cluster trial of two interventions (intervention 1: HBCP programme; intervention 2: HBCP programme + mobile health application) and usual care (control). In preparation for the onset of the study, a mobile application is being developed. Focus discussion groups will be carried out with selected patients and HBCPs after the end of the main trial to explore their opinions in participating in the study.

Study population: District hospitals from those running the HBCP programme will be selected according to criteria. Under each district hospital, the administrative areas ("cells") participating in the HBCP programme will be randomised to receive intervention 1 or 2. The patients from each group who meet the eligibility criteria of the study will receive the same intervention. Cells that do not participate in HBCP programme will be assigned to the control group.

Study endpoints: The primary outcomes will be changes in HbA1c levels. Medication adherence, mortality, complications, health-related quality of life, mental well-being and health literacy will be assessed as secondary outcomes.

Sponsor: The D²Rwanda project has received financial support by the Karen Elise Jensens Fond (Denmark), and the Universities of Aarhus and Luxembourg.

详细描述

Background: In Rwanda, diabetes mellitus (DM) prevalence has been estimated between 3.0 - 3.5%. Several factors, including an increase in screening and diagnosis programmes, the urbanization of the population, and changes in lifestyle are likely to contribute to a sharp increase in the prevalence of DM in the next decade, posing a daunting challenge for the fragile health care systems in low- and middle-income countries (LMICs). At the same time, the level of knowledge and perceptions of DM among patients is inadequate. Patients with low health literacy levels are often unable to recognise the signs and symptoms of DM, and may access their health provider late, hence presenting with more complications.

Although the majority of the Rwandan population seek care at the health centres, the Rwandan primary health care is facing a shortage of human resources. A community health worker programme was introduced in Rwanda in 2007 covering mainly infectious diseases, maternal and child health, and family planning.

In response to the need for better management of non-communicable diseases (NCDs) at the community level, the Ministry of Health of Rwanda and its partners adopted a new strategy and initiated a Home-Based Care Practitioner (HBCP) programme. Approximately 100 cells, belonging to the catchment area of nine selected hospitals, participate in the first phase of the HBCP programme (a "cell" is a small administrative area under the larger areas called "districts"). Every cell has two HBCPs, who completed high school and received six months of technical vocational education and training organised by the Ministry of Health in collaboration with its partners.

There is growing evidence for the efficacy of interventions using mobile devices (mHealth) in LMICs, particularly in improving treatment adherence, appointment compliance, data gathering, and developing support networks for health workers. In Rwanda, there is an urgent call to using mHealth interventions for the prevention and management of NCDs. The present research project responds to this by developing an mHealth intervention integrated in the current primary health care system, in support of both the DM patients and their healthcare providers.

Randomisation: The unit of randomisation will be the cluster, defined by the cell. In each cell two HBCPs work. Under each district hospital, the cells participating in the HBCP programme will be randomised to receive intervention 1 or 2. The patients from each group will receive the same intervention. An equal number of cells, out of those not participating in the HBCP programme, will be randomly selected and assigned to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in HbA1c

时间窗: Change from baseline to 12-month follow-up

次要结局

  • Number of lost appointments to the NCD clinics of the district hospitals(From baseline to 12-month follow-up)
  • Percentage of patients with at least one recording of body mass index (BMI)(Change from baseline to 12-month follow-up)
  • Creatinine(Change from baseline to 12-month follow-up)
  • Body mass index (BMI)(Change from baseline to 12-month follow-up)
  • Alcohol intake per week(Change from baseline to 12-month follow-up)
  • Change in medication adherence(Change from baseline to 6- and 12-month follow-up)
  • Number of dropouts of the NCD clinics of the district hospitals(From baseline to 12-month follow-up)
  • Mortality(From baseline to 12-month follow-up)
  • Number of complications(From baseline to 12-month follow-up)
  • Number of referrals(From baseline to 12-month follow-up)
  • Percentage of patients with at least one measurement of urine proteins (dipstick)(Change from baseline to 12-month follow-up)
  • Urine proteins (dipstick)(Change from baseline to 12-month follow-up)
  • Number of smokers(Change from baseline to 12-month follow-up)
  • Change in health literacy(Change from baseline to 12-month follow-up)
  • Change in health-related quality of life(Change from baseline to 6- and 12-month follow-up)
  • Percentage of patients with at least one measurement of HbA1c(Change from baseline to 12-month follow-up)
  • Percentage of patients with at least one measurement of fasting blood glucose (FBG) levels(Change from baseline to 12-month follow-up)
  • Percentage of patients with at least one measurement of creatinine(Change from baseline to 12-month follow-up)
  • Percentage of patients with at least one measurement of blood pressure(Change from baseline to 12-month follow-up)
  • Fasting blood glucose (FBG)(Change from baseline to 12-month follow-up)
  • Blood pressure(Change from baseline to 12-month follow-up)
  • Recorded number of smokers(Change from baseline to 12-month follow-up)
  • Number of patients with recorded pack years(Change from baseline to 12-month follow-up)
  • Number of patients with recorded alcohol intake per week(Change from baseline to 12-month follow-up)
  • Number of cigarettes per day(Change from baseline to 12-month follow-up)
  • Change in mental well-being(Change from baseline to 6- and 12-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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