跳至主要内容
临床试验/NCT01153048
NCT01153048已完成1 期

Randomized Controlled Trial on an Educative Structured Intervention by Peer Educators to Improve HbA1c of Patients With Type 2 Diabetes in the Sikasso Region in Mali

Sante Diabete Mali2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre

研究概览

简要总结

The main objective is to assess impact of the establishment of involved patients (peer educators) network in Mali. It will be conducted by a multidisciplinary team that brings together high level skills in research projects and in peer education projects. It will be conducted in one country Mali. In the country, it will be completed in one site : the region of Sikasso. This site was chosen because It meet a functional care, access to medicines and a dynamic association of diabetic patients. Peer educators and persons targeted by the project will be recruited through Post-Test Club on diabetes (PTC). PTC will be a social support club that provides on going prevention counseling, education and support services to people who have diabetes. PTC represents an important link between patients, educators and general medical services. PTC will be defined as clubs, which are facilitated by well-trained peer educators, and will have 3 objectives: to provide social and emotional support to diabetic patients, to provide assistance in daily management and living with diabetes and to provide linkage to clinical care. To lead the sessions, in clubs, we will use a very innovative methodology for peer education: the learning nests method. To evaluate, we propose a classical randomized controlled experimental (RCT) design, with randomization at the person-level. For outcome measures, we propose change in HbA1c, increase of social and emotional support and increase of linkage to clinical care. In addition to HbA1c, we propose measuring changes systolic and diastolic blood pressure and weight.

详细描述

BACKGROUND AND RATIONALE

The World Health Organization (WHO), estimates that the number of people affected by diabetes will rise from 171 million in 2000 to 366 million in 2030, representing a prevalence of 2.8% to 4.4% supposing that obesity will progress. Developing countries will then represent 76% of the world diabetic patients. This growth has justified the alarming report issued by the WHO in 2005 for a rapid mobilization on these new health needs. Access to care, treatment, education and care for complications related to diabetes is a key feature of the resolution passed by the United Nations in December 2006 on diabetes to protect people with diabetes against exclusion situation and increased vulnerability. In developing countries, the explosion of diabetes epidemic and other chronic diseases, is a direct consequence of the widespread emergence of overweight and obesity. For developing countries, the major increase of obesity, which involves both the upper classes that the popular classes, is essentially linked to the emergence of a nutritional transition defined as a gradual change of diets, including a clear increase of fats of animal origin consumption. Finally, the increase of obesity in the southern countries, thus the emergence of chronic diseases like diabetes, is strengthened by the increase of life expectancy and by the growth of physical inactivity.Education on diabetes is known through several names: education of the patient,patient's therapeutic education. All these terms question about the diabetic person's place in a continuous progress involving permanent communication with a care team and the coordination of a care programme. The therapeutic education is more and more becoming a model of care for people with diabetes. Indeed, diabetes is a complex condition, which requires an effective medical management from caregivers and a good autonomous management from the person with diabetes. This dual approach helps to promote choice of healthy lifestyles, improve the quality of life and reduce direct and indirect health costs for society. Educational approaches set up must recognize the critical and fundamental role of psychosocial factors for effective diabetes education. In 1914, Elliott Joslin published a book in which he stressed the importance of training nurses to participate to the education on diabetes and its management [10]. In 1936, insulin appeared and specialized nursing in diabetes had expanded. It became clear that nurses should develop their skills when it comes to education and counselling as well as expertise in clinical care. The publication of the DCCT studies results in 1993 and UKPDS in 1998 amended the diabetes care, from the simple reduction of glycaemia and blood pressure, to the active prevention of complications and in to the intensification of treatment. It was a turning point in the role of diabetes educator. In developed countries, diabetes educators began by considering the key aspects of the insulin doses adaptation, of the changes in eating habits and of the screening for complications, paving the way for the work of specialised nurses and of other caregivers, such as dieticians, chiropodist in diabetes education. Several studies have highlighted, in developed countries, the challenge for health professionals to implement education activities for patients. Above the consideration of the different cultural contexts, the barriers often described by professionals for the establishment of effective patient education are the availability of time and the inadequacy of the initial and continuing training. At hospital, the particular context in which education situations took place do not necessarily encourage the effective setting up of prevention and health practice in every day life. In the context of African health systems that combine low human and financial resources with a very important turn over of staff, it is very difficult to establish specific curricula for diabetes educators, but also to mobilize health staff specifically for this task. In these particular settings, the involvement of peers in the assistance in daily management and living with diabetes, the Social and emotional support and the Linkage to clinical care seems to be a perfect tighten to complement the organization of diabetes care in these countries. The reviews of several studies have shown the very positive results of this approach that can be implemented by following several methodological models. For this study we have chosen to implement and evaluate the impact of the methodology: The Learning Nests approach : Group Education focusing on understanding of key concepts and interactions with social context. This approach developed by health professionals and human sciences seems to be the best suited for the socio economic and cultural contexts which are encountered in Africa. It is based on 5 principles- the building and setting up of learning situations which are based on scientific data of the medical and social/human sciences frame (socioconstructivism, didactic, learning of adults-):

  • The integration of the context of life in developing the educational situation
  • The work on the operational dimension (use of the knowledge for the action, decision making by the learner), with the support of individual booklets (for the teacher and for the learner)
  • The intimate coupling of the educators training and the educational situations for learners
  • The implementation in a long-term programme, with precise indicators of results

METHODS

Intended Audience and Setting

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care

入排标准

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

入选标准

  • Patients treated in units diabetes in the intervention area and performing regularly consultations
  • Patients with type 2 diabetic insulin-treated or untreated
  • Poorly controlled diabetes with HbA1c ≥ 8%
  • Patients who agreed to undergo the whole process of peer education
  • Patients who agreed to carry out all biological measures included in the Protocol
  • Patients aged 30-80 years

排除标准

  • Diabetic patients not performing their monitoring units in the area of diabetes intervention
  • Patients with diabetes followed in units of the intervention area but not performing regular their consultations
  • Patients with type 1 diabetes
  • Scalable severe complications within 3 months preceding infection, complications heart disease, severe renal
  • Associated diseases threatening or vital functional
  • Refusal to participate in the study

结局指标

主要结局

compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre

次要结局

  • Study the evolution of bio clinical parameters: fasting glucose, weight, BMI, blood pressure, waist size

研究者

发起方
Sante Diabete Mali
申办方类型
Other

研究点 (2)

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