Diabetes Self-Management Education (DSME) and Its Effect on Clinical, Psychosocial, and Behavioral Outcomes

NCT03185689 | Completed

• 1 other identifier: DSME-Et
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Glycemic control; Diabetes self-management education

Outcome Measures

Primary Outcomes (1)

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

  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

  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.

Secondary Outcomes (1)

• 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.

Other Outcomes (5)

• change in health related quality of life (HRQoL)

  HRQoL over the last 24 hours was measured on baseline. A change in HRQoL over the last 24 hours will be measured 9 months after the commencement of the intervention or 14 months after commencement of the intervention.

• Level of diabetes management knowledge as measured by true/false form of simplified diabetes knowledge questionnaire (SDKS).

  Diabetes management knowledge was measured on baseline and a change in diabetes management knowledge will be measured 9 months after the commencement of the intervention or 14 months after commencement of the intervention.

• Level of confidence in performing diabetes self-care behaviors as measured by Diabetes Self-Efficacy Scale developed by Standford Patient Education Research Center

  Level of confidence in performing diabetes self-care behaviors was measured on baseline. A change in level of confidence will be measured 9 months after the commencement of the intervention or 14 months after commencement of the intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

Effectiveness of an intensified DSME in T2D adult patients

Behavioral: Effectiveness of an intensified DSME in T2D adult patients

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.

Interventions

Effectiveness of an intensified DSME in T2D adult patients BEHAVIORAL

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jimma University: lead

Related Publications (13)

• Mendis S, Davis S, Norrving B. Organizational update: the world health organization global status report on noncommunicable diseases 2014; one more landmark step in the combat against stroke and vascular disease. Stroke. 2015 May;46(5):e121-2. doi: 10.1161/STROKEAHA.115.008097. Epub 2015 Apr 14. No abstract available.

  PMID: 25873596 BACKGROUND

• Barr VJ, Robinson S, Marin-Link B, Underhill L, Dotts A, Ravensdale D, Salivaras S. The expanded Chronic Care Model: an integration of concepts and strategies from population health promotion and the Chronic Care Model. Hosp Q. 2003;7(1):73-82. doi: 10.12927/hcq.2003.16763.

  PMID: 14674182 BACKGROUND

• Idemyor V. Diabetes in sub-Saharan Africa: health care perspectives, challenges, and the economic burden of disease. J Natl Med Assoc. 2010 Jul;102(7):650-3. doi: 10.1016/s0027-9684(15)30643-x.

  PMID: 20690330 BACKGROUND

• Peer N, Kengne AP, Motala AA, Mbanya JC. Diabetes in the Africa Region: an update. Diabetes Res Clin Pract. 2014 Feb;103(2):197-205. doi: 10.1016/j.diabres.2013.11.006. Epub 2013 Dec 1.

  PMID: 24315460 BACKGROUND

• Beran D. The Diabetes Foundation Report on implementing national diabetes programmes in sub-Saharan Africa, 2006. International Insulin Foundation: London.

  BACKGROUND

• Beran D, Yudkin JS. Diabetes care in sub-Saharan Africa. Lancet. 2006 Nov 11;368(9548):1689-95. doi: 10.1016/S0140-6736(06)69704-3.

  PMID: 17098088 BACKGROUND

• Snoek Fj, Visser A. Improving quality of life in diabetes: how effective is education? Patient Educ Couns. 2003 Sep;51(1):1-3. doi: 10.1016/s0738-3991(03)00204-0. No abstract available.

  PMID: 12915274 BACKGROUND

• Tuei VC, Maiyoh GK, Ha CE. Type 2 diabetes mellitus and obesity in sub-Saharan Africa. Diabetes Metab Res Rev. 2010 Sep;26(6):433-45. doi: 10.1002/dmrr.1106.

  PMID: 20641142 BACKGROUND

• Fisher EB, Boothroyd RI, Coufal MM, Baumann LC, Mbanya JC, Rotheram-Borus MJ, Sanguanprasit B, Tanasugarn C. Peer support for self-management of diabetes improved outcomes in international settings. Health Aff (Millwood). 2012 Jan;31(1):130-9. doi: 10.1377/hlthaff.2011.0914.

  PMID: 22232103 BACKGROUND

• MakkiAwouda FO, Elmukashfi TA, Hag Al-Tom SA. Effects of health education of diabetic patient's knowledge at Diabetic Health Centers, Khartoum State, Sudan: 2007-2010. Glob J Health Sci. 2014 Feb 14;6(2):221-6. doi: 10.5539/gjhs.v6n2p221.

  PMID: 24576384 BACKGROUND

• Mash RJ, Rhode H, Zwarenstein M, Rollnick S, Lombard C, Steyn K, Levitt N. Effectiveness of a group diabetes education programme in under-served communities in South Africa: a pragmatic cluster randomized controlled trial. Diabet Med. 2014 Aug;31(8):987-93. doi: 10.1111/dme.12475. Epub 2014 May 20.

  PMID: 24766179 BACKGROUND

• Hailu FB, Moen A, Hjortdahl P. Diabetes Self-Management Education (DSME) - Effect on Knowledge, Self-Care Behavior, and Self-Efficacy Among Type 2 Diabetes Patients in Ethiopia: A Controlled Clinical Trial. Diabetes Metab Syndr Obes. 2019 Nov 29;12:2489-2499. doi: 10.2147/DMSO.S223123. eCollection 2019.

  PMID: 31819574 DERIVED

• Hailu FB, Hjortdahl P, Moen A. Nurse-Led Diabetes Self-Management Education Improves Clinical Parameters in Ethiopia. Front Public Health. 2018 Oct 23;6:302. doi: 10.3389/fpubh.2018.00302. eCollection 2018.

  PMID: 30406070 DERIVED

Related Links

• Global status report on noncommunicable diseases 2010
• Type 2 diabetes mellitus and obesity in sub-Saharan Africa
• Effects of Health Education of Diabetic Patient's Knowledge at Diabetic Health Centers, Khartoum State, Sudan: 2007-2010
• Educational and Psychological Issues Effectiveness of a group diabetes education programme in under-served communities in South Africa: a pragmatic cluster randomized controlled trial
• Determinants of glycemic control among insulin treated diabetic patients in Southwest Ethiopia: hospital based cross sectional study.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Fikadu B Hailu, PhD Fellow

  Jimma University

  PRINCIPAL INVESTIGATOR

• Anne Moen, PhD

  University of Oslo

  STUDY CHAIR

• Per Hjortdahl, PhD

  University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: DSME is model assumed to empower diabetes patients in the area of self-care practice. To bring this behavioral change it has been hypothesized that an intensified DSME which is given in organized, interlinked and supported by take home activities is effective in glycemic control. As a teaching material, illustrative booklet was prepared in two local languages. Similarly, fliers have been given following each DSME session. Specifically for educational sessions, copy of the booklet was prepared in larger posters. The education is not only one way type of education, rather there have been a vast experience sharing among the patient, whether they have been doing in the recommended way or not. Then the facilitator educate them what is right and recommended. Local culture, values and beliefs were taken into account on each of the sessions.

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 14, 2017
• Study Start: April 4, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 17, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share