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临床试验/NCT03185689
NCT03185689已完成不适用

Effect of Diabetic Self-management Education (DSME) on Clinical, Psychosocial, and Behavioral Outcomes Among People With Type 2 Diabetes Attending Jimma University Medical Center (JUMC)

Jimma University0 个研究点目标入组 240 人开始时间: 2016年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
主要终点
Proportion of T2D patients with controlled BGL as measured by a change in HbA1c

研究概览

简要总结

In relation to rapid urbanization, demographic transition and childhood conditions obesity and type 2 diabetes (T2D) is increasing in an alarming rate in Africa. With an increase in the rate of diabetes in Ethiopia, responses to reduce its occurrence and delaying or preventing complications is not adequate. One of these strategies is empowerment of diabetes patients on self-care.

The main objective of this project is to assess effects of phased and intensified DSME on psycho-social, clinical, and behavioral outcomes among adults with T2D in Ethiopia.

An interventional two groups study design was employed to determine the desired effect of DSME. The study participants were selected randomly from adult T2D patients attending Jimma University Medical Center (JUMC) chronic illness follow-up clinic. Using the assumption of increasing the proportion of people with controlled blood glucose from 18% to 33% the sample was calculated 120 with participants in the intervention group and 120 in the comparison group.

To reduce risk of contamination, we planned to vary the intervention and the comparison group based on their residence using kebele (the smallest administrative unit) for residents of Jimma town and woreda or district for those outside of Jimma town. Because of the inconvenience to vary days of appointment, where those supposed to come on Monday were coming on Tuesday and those supposed to come on Monday were coming on Tuesday, that created a high risk of mix-up of participants. Because of this reason, though the baseline was collected from February 2016 to May 2016, the intervention was delayed by five months and then started on November.

Face to face group-based DSME has been given to the intervention group from November 2016 to April 2017. Then the participants will be further followed for three months to determine the effect of phased and intensified DSME on the control of BGL as measured by HbA1c.

In order to make it culture-friendly educational materials were prepared with two widely used languages, Amharic and Afan Oromoo. First, the teaching materials were prepared in English then translated to Amharic and Afan Oromoo separately by bilingual experts. Then, different bilingual experts back translated to English. Finally, with these experts, common discussion was made and the final teaching materials were produced. The package of teaching materials includes booklets, fliers, and posters prepared in both languages.

详细描述

As incidence and prevalence of non-communicable chronic diseases (NCDs) is increasing, care of individuals with NCDs become challenging, complex and expensive (1). One of the models used for the management of NCDs is the mode developed by Wagner and his colleagues in 1990s. Of the six components of the model self-management support has been identified and customized to diabetic care which helps to assist diabetic patients to overcome attitudinal and motivational barriers, improve their self-management skills and feelings of self-efficacy (2).

The objective of DSME is to support the individual to make informed decision, cope with daily demands of diabetes, make behavioral changes that support their self-care practice, active collaboration with the health care team and improve clinical outcomes, health status, and quality of life (3, 4).

In some of developed countries, it was found that DSME is effective in reducing HbA1c, BGL, BP, BMI, anxiety, need for diabetes medication and risk of complications as well as improve diabetes knowledge, sound activity, diet, self-care practice, quality of life (5-8).

Though very few intervention studies related to DSME are conducted in a very few countries (9-12), the role of culture friendly DSME in Africa is not well understood. In addition, since Africa has a different living style, culture, belief, and probably different risk factors of diabetes as well, the effectiveness of DSME is not well understood and it has not been given a due attention. Similarly, in Ethiopia despite large number of people with diabetes, so far to our knowledge no organized DSME has been developed, tested and implemented.

Therefore, exploring effectiveness of DSME in Ethiopian context is paramount. The findings from this study can be important to help patients living with Diabetes 2 to leave healthier life by reducing/preventing the occurrence of complications. Moreover, it may initiate policy makers, health planners and other relevant stakeholders about importance of diabetes control using self-management education and support. At the same time, self-management is expected to contribute to improve clinical outcome, reduce risk factors, prevent or delay of disabilities and ultimately improve the quality of life for the individuals and their families. This may in turn enables societal members to participate in the country's economic growth and development. The findings of this study will also be used as a baseline for future related studies. The finding of the study can also be used as a starting point for the Ethiopian Federal Ministry of Health (FMoH) and the respective regional health bureaus to develop and implement culturally friendly DSME model. Moreover, it can initiate relevant bodies to design short-term and long-term curriculum for training of relevant front line health care providers, like nurses or community health workers, who will have a central role in the support of clients with diabetes.

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
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

入选标准

  • Adults 18 years and older with confirmed T2DM (as diagnosed by physicians and based on the history of medicines they have been taking) were recruited. People with T2DM and other co-morbid diseases like cardiovascular diseases were included.

排除标准

  • Patients with diabetes type 1, gestational diabetes, pregnant women and people with severe cognitive impairment or terminally ill people were excluded

研究组 & 干预措施

Intervention group

Experimental

Effectiveness of an intensified DSME in T2D adult patients

干预措施: Effectiveness of an intensified DSME in T2D adult patients (Behavioral)

Comparison group

No Intervention

The comparison group have got the usual traditional way of education, which is given occasionally for all of diabetes patients at waiting area. Other than this, the comparison group didn't get an organized and intensified DSME.

结局指标

主要结局

Proportion of T2D patients with controlled BGL as measured by a change in HbA1c

时间窗: HbA1c was measured on baseline, which was done 5 months before the commencement of the intervention. A change in HbA1c will be measured 9 months after the commencement of the intervention or 14 months after commencement of the intervention.

The glycemic control is measured by the level of HbA1c where HbA1c\>=7% indicates poorly controlled diabetes and \<7% well controlled roughly over the last three months

次要结局

  • Proportion of T2D patients with a recommended level of diabetes self-care behavior as measured by summary of diabetes self-care activities (SDSCA) questionnaire(Proportion of T2D patients with the recommended level of diabetes self-care behavior was measured on baseline. Behavioral change will be measured 9 months after the commencement of the intervention or 14 months after commencement of the intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fikadu Balcha Hailu

Principal Investigator

Jimma University

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