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ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Effectiveness of an intensified DSME in T2D adult patientsbehavioral
Likely dose
Not stated in record
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Search/NCT03185689
NCT03185689N/ACompleted

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 University·interventional·Posted Jun 14, 2017·Updated Oct 31, 2017

In Brief

A clinical study evaluating Effectiveness of an intensified DSME in T2D adult patients for Diabetes Mellitus, Type 2. Completed, enrolled 240 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartApr 4, 2016
Primary CompletionAug 1, 2017
Study CompletionOct 17, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.0 years ago

Interventions

Effectiveness of an intensified DSME in T2D adult patientsbehavioral