The Efficacy of Primary and Tertiary Specialist Care Collaboration and Mobile Complications Screening for Improving the Management of Diabetes at Primary Health Care Level in Tshwane District - A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change in HbA1c values between year 1 and year 2
研究概览
简要总结
A pragmatic cluster randomised controlled trial will be done where the intervention will be a mobile screening team visiting selected PHC facilities in Tshwane district. It will provide education and screening for diabetic complications (foot, kidney, cardiac and retinal complications). Six clinics will receive the intervention and six clinics will serve as controls. Six hundred patients will be recruited (2 x 300).
The screening results will be evaluated by an expert panel at tertiary care level and an individualised patient management plan will be compiled. This plan will be communicated to the family physician and integration team at the clinic for further management or referral of the patients. Laser therapy will be available on the mobile clinic for patients that require it (as assessed by an Ophthalmologist who will review the retinal photos).
A baseline evaluation (including HbA1c, serum creatinine, lipogram and urine albumin-creatinine ratio) will be done to determine current disease management at patient and health facility level, followed by the intervention and a follow-up visit a year later. The main outcome measures are glucose, lipid and blood pressure control as well as the percentage of patients screened and referred for diabetes complications.
A cost effectiveness analysis will be done to estimate the added cost per added complication prevented or referred.
The potential implications for improving diabetes care and preventing long term complications are extremely important. The study results will be used to help plan future health care services for people with diabetes mellitus in the region.
详细描述
Diabetes Mellitus (DM) is a major metabolic disease that is characterised by a reduced or impaired capability of the body to regulate its blood glucose levels. The disease is now reaching pandemic levels. The global prevalence for DM (across all age groups) was estimated to be 2,8% in 2000, and it will rise to 4,4% by 2030. In real numbers this implies from 171 million people to 366 million people will be affected globally. This rise will certainly have an impact of the health care system of many countries. Most of the DM patients will be managed at primary health care level.
It has become clear that the difficulties in achieving a satisfactory level of health care delivery for DM patients are not related to the availability of knowledge of the disease, nor the best diagnostic and therapeutic procedures, but rather to system and organisational problems. Many of the complications of diabetes are potentially preventable or can be minimized if earlier action has been taken. The chronic nature of the disease and the need for the empowerment of the patient and the health workers in understanding the disease to ensure optimal glucose control makes DM an ideal disease to test new models of health care delivery which can include patient empowerment, health worker empowerment and the use of telemedicine and E-Health .
It is believed that the current primary health care approach is not allowing for sufficient time and personnel to provide patients with optimal care and to screen for diabetic complications. Currently only the blood pressure and random blood glucose measures are taken at Primary Health Care (PHC) facilities, even though the national policy for the management of diabetes prescribes the monitoring of complications at least once a year.
This study investigates the benefits of a comprehensive mobile screening effort to identify and to improve the early detection of diabetes-related complications. With the expected improvement in disease management and patient specific outcomes, this study will contribute to policy changes for diabetes management at primary health care level.
This study differs from other studies that evaluated complications in isolation. It aims to evaluate the efficacy of a complex intervention that provides an interface for Specialist from Family Medicine and Internal Medicine to collaborate and includes a mobile comprehensive complication screening service. The study also provides opportunity for training of clinic staff as well exposure and training of Clinical Associates regarding diabetes care and complication screening and management. It is envisaged that the structured screening and review programme will provide evidence for ways to ensure future collaboration enhancing diabetes patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Clinical diagnosis of diabetes
- •All type 2 diabetics and type 1 diabetics with minimum of 5 years duration
- •Above 18 years of age
排除标准
- •Diabetics below 18 years of age
- •Type 1 diabetics with duration of disease less than 5 years
结局指标
主要结局
Change in HbA1c values between year 1 and year 2
时间窗: 2 Years
Descriptive demographics of participants
时间窗: 1 Year
Between group differences in patients with detected neuropathy, nephropathy and retinopathy
时间窗: 2 Years
Between group differences in HbA1c categories
时间窗: 1 year
次要结局
- Between group differences in complications detected(2 Years)
- Between group differences in referred patients for complication assessment or care(1 Year)
- Between group differences in blood pressure and lipid control(1 Year)
- To cost the intervention and evaluate additional costs per complication detected(1 Year)
- Collection of cross sectional data regarding complications and metabolic control from patients not enrolled in the trial but who are attending screening visits by the mobile team(1 Year)
- Between group differences in patients where LDL cholestrol and creatinine was measures(2 years)
