Effect of Peer Support Intervention on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes

NCT07145983 | Completed Results DMC

• 2 other identifiers: Addis Ababa University(AAU)084/24/SoP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to learn about the effect of a peer support group intervention on adherence, self-care practice, and knowledge among diabetic patients on follow-up care. The main question it aims to answer is:

• Does participation in a peer support group improve medication adherence, self-care behaviors, and diabetes knowledge compared to standard care?
• Participants with diabetes who are already receiving follow-up care at Ayder Comprehensive Specialized Hospital(ACSH) will be randomly assigned to either a peer support group (intervention group) or continue their usual follow-up care (control group). Outcomes will be measured through validated questionnaires and pill counts over the study period.

Conditions

Peer Influence; Self Care; Medication Adherence

Keywords

Diabetes Mullites; Peer support; Medication adherence; self-care Practice; Diabetes Knowledge

Outcome Measures

Primary Outcomes (3)

• Medication Adherence Status

  Medication adherence of each group was assessed through a mixed method using the Morisky Medication Adherence Scale (MMAS-8) and self-reported pill count. The Morisky Medication Adherence Scale consisted of seven dichotomous items and one item rated on a five-point Likert scale which provided five response options, scored from 0 to 1 in 0.25-point increments. Based on the total score, patients were classified as low adherers (score \<6), medium adherers (score 6 to \<8),or high adherers (score = 8).

  Baseline and 6 months

• Overall Diabetes Self-Care Practice Score

  Overall diabetes self-care practice was assessed using a standardized self-care questionnaire covering multiple domains, including general diet, specific diet, physical activity, blood glucose monitoring, foot care, and adherence to health care provider recommendations. A composite self-care practice score was calculated and participants were categorized as having good self care practice if a mean scored of 3.5 and greater days per week and poor self-care practice if mean scored less than 3.5days per week.The higher scores mean a better outcome.

  Baseline and 6 months

• Diabetes Knowledge Status

  Diabetes-related knowledge was assessed using a validated instrument designed to measure patients' knowledge related to diabetes management. The questionnaire included 14 core items administered to all participants. An additional 9 items were administered to insulin users, resulting in a total possible score ranging from minimum(0)to Maximum score (14) for non-insulin users and minimum(0) to maximum(23) for insulin users. Each correct response was assigned one point, and item scores were summed to generate a total diabetes knowledge score. Higher scores indicate better diabetes-related knowledge. For interpretation, participants scoring at least 50% of the maximum possible score for their respective category (≥7 for non-insulin users and ≥11.5 for insulin users) were classified as having good diabetes-related knowledge, while those scoring less than 50% were classified as having poor diabetes-related knowledge.T

  Baseline and 6 months

Secondary Outcomes (1)

• Medication Adherence Status by Pill Count

  Baseline and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive peer-led support sessions in addition to usual diabetes care.

Behavioral: Structured Diabetes Education on medication Adherence and self care

No-Intervention Comparator: Standard Care Alone(Control group)

NO INTERVENTION

Participants continue with routine follow-up and standard diabetes care only.

Interventions

Structured Diabetes Education on medication Adherence and self care BEHAVIORAL

Lived-experience facilitation, goal setting, real-world problem solving, and ongoing peer accountability not provided in standard clinician-led education. Peer-led, group-based sessions emphasizing lived experiences, problem-solving, and mutual support. Participants meet regularly in small groups facilitated by trained peers with diabetes. Includes structured booster follow-ups and SMS reminders to reinforce adherence and self-care.

Also known as: Structured Diabetes Education on Diabetes definition, sign and symptoms and management

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Clincal Diagnosis of Diebetes mullites's Disease
• Must be on at least one diabetes medication
• Must had at least two concicative follow-up visits at the Diabetes clinic

You may not qualify if:

• Declined to participate in any of the group
• Concurrent endocrine disorders (thyroid disease, obesity, or gestational diabetes)
• Chronic diseases (cardiac heart failure, hepatitis and cancer)
• Enrollement in other educational programs during the study period those who
• Health professionals with diabetes

Sponsors & Collaborators

• Addis Ababa University: lead
• Mekelle University: collaborator

Study Sites (1)

Ayder Comprehensive Specialized Hospital (Mekelle University Hospital)

Mek'ele, Tigray, 86, Ethiopia

Location

Related Publications (16)

• Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th edition. Brussels: International Diabetes Federation; 2021. Available from http://www.ncbi.nlm.nih.gov/books/NBK581934/

  PMID: 35914061 BACKGROUND

• Atun R, Davies JI, Gale EAM, Barnighausen T, Beran D, Kengne AP, Levitt NS, Mangugu FW, Nyirenda MJ, Ogle GD, Ramaiya K, Sewankambo NK, Sobngwi E, Tesfaye S, Yudkin JS, Basu S, Bommer C, Heesemann E, Manne-Goehler J, Postolovska I, Sagalova V, Vollmer S, Abbas ZG, Ammon B, Angamo MT, Annamreddi A, Awasthi A, Besancon S, Bhadriraju S, Binagwaho A, Burgess PI, Burton MJ, Chai J, Chilunga FP, Chipendo P, Conn A, Joel DR, Eagan AW, Gishoma C, Ho J, Jong S, Kakarmath SS, Khan Y, Kharel R, Kyle MA, Lee SC, Lichtman A, Malm CP, Mbaye MN, Muhimpundu MA, Mwagomba BM, Mwangi KJ, Nair M, Niyonsenga SP, Njuguna B, Okafor OLO, Okunade O, Park PH, Pastakia SD, Pekny C, Reja A, Rotimi CN, Rwunganira S, Sando D, Sarriera G, Sharma A, Sidibe A, Siraj ES, Syed AS, Van Acker K, Werfalli M. Diabetes in sub-Saharan Africa: from clinical care to health policy. Lancet Diabetes Endocrinol. 2017 Aug;5(8):622-667. doi: 10.1016/S2213-8587(17)30181-X. Epub 2017 Jul 5. No abstract available.

  PMID: 28688818 BACKGROUND

• Gebreyohannes EA, Netere AK, Belachew SA. Glycemic control among diabetic patients in Ethiopia: A systematic review and meta-analysis. PLoS One. 2019 Aug 27;14(8):e0221790. doi: 10.1371/journal.pone.0221790. eCollection 2019.

  PMID: 31454396 BACKGROUND

• Fisher EB, Boothroyd RI, Elstad EA, Hays L, Henes A, Maslow GR, Velicer C. Peer support of complex health behaviors in prevention and disease management with special reference to diabetes: systematic reviews. Clin Diabetes Endocrinol. 2017 May 25;3:4. doi: 10.1186/s40842-017-0042-3. eCollection 2017.

  PMID: 28702258 BACKGROUND

• Funnell MM. Peer-based behavioural strategies to improve chronic disease self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Fam Pract. 2010 Jun;27 Suppl 1(Suppl 1):i17-22. doi: 10.1093/fampra/cmp027. Epub 2009 Jun 9.

  PMID: 19509083 BACKGROUND

• Azmiardi A, Murti B, Febrinasari RP, Tamtomo DG. The effect of peer support in diabetes self-management education on glycemic control in patients with type 2 diabetes: a systematic review and meta-analysis. Epidemiol Health. 2021;43:e2021090. doi: 10.4178/epih.e2021090. Epub 2021 Oct 22.

  PMID: 34696569 BACKGROUND

• Gutierrez AP, Fortmann AL, Savin K, Clark TL, Gallo LC. Effectiveness of Diabetes Self-Management Education Programs for US Latinos at Improving Emotional Distress: A Systematic Review. Diabetes Educ. 2019 Feb;45(1):13-33. doi: 10.1177/0145721718819451. Epub 2018 Dec 20.

  PMID: 30569831 BACKGROUND

• Debussche X, Besancon S, Balcou-Debussche M, Ferdynus C, Delisle H, Huiart L, Sidibe AT. Structured peer-led diabetes self-management and support in a low-income country: The ST2EP randomised controlled trial in Mali. PLoS One. 2018 Jan 22;13(1):e0191262. doi: 10.1371/journal.pone.0191262. eCollection 2018.

  PMID: 29357380 BACKGROUND

• Khare J, Jindal S. Observational study on Effect of Lock Down due to COVID 19 on glycemic control in patients with Diabetes: Experience from Central India. Diabetes Metab Syndr. 2020 Nov-Dec;14(6):1571-1574. doi: 10.1016/j.dsx.2020.08.012. Epub 2020 Aug 20.

  PMID: 32858474 BACKGROUND

• Lee AA, Piette JD, Heisler M, Janevic MR, Rosland AM. Diabetes self-management and glycemic control: The role of autonomy support from informal health supporters. Health Psychol. 2019 Feb;38(2):122-132. doi: 10.1037/hea0000710.

  PMID: 30652911 BACKGROUND

• Shiyanbola OO, Maurer M, Mott M, Schwerer L, Sarkarati N, Sharp LK, Ward E. A feasibility pilot trial of a peer-support educational behavioral intervention to improve diabetes medication adherence in African Americans. Pilot Feasibility Stud. 2022 Nov 14;8(1):240. doi: 10.1186/s40814-022-01198-7.

  PMID: 36376960 BACKGROUND

• Edelman SV, Polonsky WH. Type 2 Diabetes in the Real World: The Elusive Nature of Glycemic Control. Diabetes Care. 2017 Nov;40(11):1425-1432. doi: 10.2337/dc16-1974. Epub 2017 Aug 11.

  PMID: 28801473 BACKGROUND

• Burudpakdee C, Khan ZM, Gala S, Nanavaty M, Kaura S. Impact of patient programs on adherence and persistence in inflammatory and immunologic diseases: a meta-analysis. Patient Prefer Adherence. 2015 Mar 11;9:435-48. doi: 10.2147/PPA.S77053. eCollection 2015.

  PMID: 25792817 BACKGROUND

• Zachariah R, Teck R, Buhendwa L, Fitzerland M, Labana S, Chinji C, Humblet P, Harries AD. Community support is associated with better antiretroviral treatment outcomes in a resource-limited rural district in Malawi. Trans R Soc Trop Med Hyg. 2007 Jan;101(1):79-84. doi: 10.1016/j.trstmh.2006.05.010. Epub 2006 Sep 8.

  PMID: 16962622 BACKGROUND

• Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.

  PMID: 18453793 BACKGROUND

• Fitzgerald JT, Funnell MM, Hess GE, Barr PA, Anderson RM, Hiss RG, Davis WK. The reliability and validity of a brief diabetes knowledge test. Diabetes Care. 1998 May;21(5):706-10. doi: 10.2337/diacare.21.5.706.

  PMID: 9589228 RESULT

Related Links

• World Health Organization. Adherence to long-term therapies: evidence for action.
• Book chapter on assessing diabetes self-management summary diabetes self-care activities questionnaire

MeSH Terms

Conditions

Medication Adherence

Interventions

Self Care; Therapeutics

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

* Short period(only 3 times) of contact with intervention groups. * Insufficient number of study group participants for inference

Results Point of Contact

• Title: Halefom Kahsay Haile
• Organization: Addis Ababa University

heleka94@gmail.com

914257964

Study Officials

• Halefom K Haile, Msc

  Addis Ababa University, Adigrat university

  PRINCIPAL INVESTIGATOR

• Teferi G Fenta, Professor

  Addis Ababa University

  STUDY CHAIR

• Bruck M Habte, PhD

  Addis Ababa University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: December 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 1, 2025
• Last Updated: March 12, 2026
• Results First Posted: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)