Peer InfluenceDMNCT07145983
Effect of Peer Support Intervention on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes
A study testing Structured Diabetes Education on medication Adherence and self care in people with Peer Influence and Medication Adherence, run by Addis Ababa University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peer Influence, Medication Adherence, Self Care
- What is being tested?
- Structured Diabetes Education on medication Adherence and self care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Dec 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Ayder Comprehensive Specialized Hospital (Mekelle University Hospital)
Mek'ele, Tigray, 86
About this study
Official title: Peer Support Intervention Effect on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes: A Randomized Control Trial
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.
Read the detailed description
BACKGROUND Diabetes mellitus (DM) is a chronic metabolic disorder that comes as one of the fastest-growing global health challenges, with the number of affected individuals projected to reach 643 million by 2030 and 783 million by 2045. Sub-Saharan Africa is experiencing a rapid rise in DM prevalence, partly due to urbanization, lifestyle changes, and limited access to preventive and treatment services. In Ethiopia, diabetes contributes substantially to the burden of non-communicable diseases, yet many patients fail to achieve optimal glycemic control.
Peer support is considered a promising, feasible, and culturally appropriate enhancement to diabetes care, enabling participants to assist one another in their ongoing self-management efforts. It is effective in preventing the complications of diabetes and enhancing health outcomes in patients with diabetes. Previous systematic reviews have reported that programs were effective for diabetes outcomes, including glycemic control, knowledge of diabetes, self-management skills, and self-efficacy. A healthy lifestyle, an appropriate diet, and medication adherence among diabetic patients are essential factors in the prevention of diabetes complications as well as maintaining good glycemic control. However, many patients with diabetes fail to manage the disease due to its complex nature. Hence, patients with diabetes need self-management education to assist them in comprehending and dealing with the disease.
Several rigorous reviews have demonstrated that adherence to treatment among patients with chronic diseases in developed countries is about 50%. Considering the scarcity and inequities in access to healthcare services in developing countries, this rate is assumed to be even lower. Poor adherence to diabetes medications is common among African Americans and contributes to these disproportionally worse outcomes. Numerous studies suggested that diabetic peer support programs have positive outcomes on improvement of adherence to medication which is essential for successful diabetes management. For example, Shiyanbola and coworker supported that conduction of an efficacy trial to address medication adherence using a peer-supported tailored intervention is essential. The healthcare effectiveness report from united states (US) point out that inadequate medication adherence is one of the main causes of the differences in glycemic control attainment rates between real-world settings and randomized controlled trials, which emphasizes the need for better provider and patient support programs to improve adherence. Thus, Patient support programs can improve persistence with and/or adherence to medications for the treatment of chronic diseases like diabetes.
Sub-Saharan Africa researches have demonstrated that peer support programs are beneficial and enable participants to modify their lifestyle and adhere to treatment. A study conducted in Uganda showed that improvements in eating habits, diastolic blood pressure, and glycosylated hemoglobin (HbA1c), after peer support program had carried out to diabetic patients and concluded that as it is a workable intervention to enhance diabetes care in health care settings. Additionally, diabetes peer support programs have been demonstrated to enhance patients' health-related behaviors, metabolic management, and quality of life in nations such as South Africa, and Cameroon. After the diabetes peer support program has positively impacted its members in Malawi, the researchers suggested that additional recruitment and ongoing training for peer supporters is necessary to reinforce and update management knowledge and skills. Besides, they concluded that it is a viable strategy for the non-communicable diseases unit within the Ministry of Health. In Ethiopia, fewer than 50% of diabetic individuals obtain proper diabetes care.
Despite the empirical studies showing positive and significant relationships between diabetes peer support and treatment adherence among patients with diabetes, the exact mechanism by which peer support affects patient adherence is not yet completely understood. Further research is needed to address how the differences in types of support, such as functional or emotional support, are linked to outcomes for patients. Specifically, there remains a gap in understanding what constitutes peer support and how to effectively implement it in low-resource environments, like Ethiopia health care settings.
Patient education materials provided by diabetes focused organizations do not increase patient self efficacy or engagement with self management as these documents contain complex medical jargon and provide only general guidelines, not patient-specific instruction. Peer support interventions, where individuals with lived experience of diabetes share advice, encouragement, and practical strategies, offer a potentially powerful extension of these existing support systems. Such programs have demonstrated benefits in enhancing treatment adherence, self-care practices, and disease-related knowledge in various settings. Despite this, there is limited data from Ethiopia on the effect of structured peer support groups among patients receiving care in tertiary hospitals.
This study assesses the effectiveness of a structured peer support group in enhancing medication adherence, self-care behaviors, and diabetes-related knowledge among adult patients attending follow-up at ACSH, a tertiary care facility in northern Ethiopia. The findings aim to inform efforts to integrate peer support into routine diabetes care within similar low-resource environments.
- Conditions
- Peer Influence, Medication Adherence, Self Care
- Being tested
- Structured Diabetes Education on medication Adherence and self care
- Keywords
- Diabetes Mullites, Peer support, Medication adherence, self-care Practice, Diabetes Knowledge
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Diabetes Education on medication Adherence and self careBehavioural
Also called Structured Diabetes Education on Diabetes definition, sign and symptoms and management
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive peer-led support sessions in addition to usual diabetes care. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: Baseline and 6 months
Secondary outcomes (1)
Medication Adherence Status by Pill Count
Pill count data were obtained at each assessment round to evaluate actual medication use. Adherence was calculated by subtracting the number of pills remaining from the quantity dispensed, dividing the result by the product of the prescribed daily dose and the number of days since the last refill, and then multiplying by 100 to obtain a percentage. Patients with adherence below 80% were classified as poor adhrence, and those with above 80% were classified as good adhrence.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Dec 2024
- Primary completion30 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Peer InfluenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addis Ababa University
- Sponsor type
- University, hospital or other
- Collaborators
- Mekelle University
- Responsible party
- Principal investigator, Halefom Kahsay Haile, Addis Ababa University
- Investigators
- Halefom K Haile, Msc, Principal investigator, Addis Ababa University, Adigrat universityTeferi G Fenta, Professor, Study chair, Addis Ababa UniversityBruck M Habte, PhD, Study director, Addis Ababa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145983
- Sponsor's protocol ID
- Addis Ababa University(AAU)
- Other IDs
- 084/24/SoP
- Acronym
- DM
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2025
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, our data needs clearance,organization and documentation
Publications
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/
PubMed 35914061Atun 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.
PubMed 28688818Gebreyohannes 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.
PubMed 31454396Fisher 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.
PubMed 28702258Funnell 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.
PubMed 19509083Azmiardi 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.
PubMed 34696569Gutierrez 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.
PubMed 30569831Debussche 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.
PubMed 29357380Khare 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.
PubMed 32858474Lee 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.
PubMed 30652911Shiyanbola 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.
PubMed 36376960Edelman 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.
PubMed 28801473Burudpakdee 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.
PubMed 25792817Zachariah 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.
PubMed 16962622Morisky 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.
PubMed 18453793
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support Intervention Effect on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07145983
- Acronym / sponsor ID
- DM / Addis Ababa University(AAU)
- Conditions
- Peer Influence, Medication Adherence, Self Care
- Keywords
- Diabetes Mullites, Peer support, Medication adherence, self-care Practice, Diabetes Knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Addis Ababa UniversityUniversity, hospital or other
- Collaborators
- Mekelle University
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Posted 18 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Diabetes mellitus (DM) is a chronic metabolic disorder that comes as one of the fastest-growing global health challenges, with the number of affected individuals projected to reach 643 million by 2030 and 783 million by 2045. Sub-Saharan Africa is experiencing a rapid rise in DM prevalence, partly due to urbanization, lifestyle changes, and limited access to preventive and treatment services. In Ethiopia, diabetes contributes substantially to the burden of non-communicable diseases, yet many patients fail to achieve optimal glycemic control.
Peer support is considered a promising, feasible, and culturally appropriate enhancement to diabetes care, enabling participants to assist one another in their ongoing self-management efforts. It is effective in preventing the complications of diabetes and enhancing health outcomes in patients with diabetes. Previous systematic reviews have reported that programs were effective for diabetes outcomes, including glycemic control, knowledge of diabetes, self-management skills, and self-efficacy. A healthy lifestyle, an appropriate diet, and medication adherence among diabetic patients are essential factors in the prevention of diabetes complications as well as maintaining good glycemic control. However, many patients with diabetes fail to manage the disease due to its complex nature. Hence, patients with diabetes need self-management education to assist them in comprehending and dealing with the disease.
Several rigorous reviews have demonstrated that adherence to treatment among patients with chronic diseases in developed countries is about 50%. Considering the scarcity and inequities in access to healthcare services in developing countries, this rate is assumed to be even lower. Poor adherence to diabetes medications is common among African Americans and contributes to these disproportionally worse outcomes. Numerous studies suggested that diabetic peer support programs have positive outcomes on improvement of adherence to medication which is essential for successful diabetes management. For example, Shiyanbola and coworker supported that conduction of an efficacy trial to address medication adherence using a peer-supported tailored intervention is essential. The healthcare effectiveness report from united states (US) point out that inadequate medication adherence is one of the main causes of the differences in glycemic control attainment rates between real-world settings and randomized controlled trials, which emphasizes the need for better provider and patient support programs to improve adherence. Thus, Patient support programs can improve persistence with and/or adherence to medications for the treatment of chronic diseases like diabetes.
Sub-Saharan Africa researches have demonstrated that peer support programs are beneficial and enable participants to modify their lifestyle and adhere to treatment. A study conducted in Uganda showed that improvements in eating habits, diastolic blood pressure, and glycosylated hemoglobin (HbA1c), after peer support program had carried out to diabetic patients and concluded that as it is a workable intervention to enhance diabetes care in health care settings. Additionally, diabetes peer support programs have been demonstrated to enhance patients' health-related behaviors, metabolic management, and quality of life in nations such as South Africa, and Cameroon. After the diabetes peer support program has positively impacted its members in Malawi, the researchers suggested that additional recruitment and ongoing training for peer supporters is necessary to reinforce and update management knowledge and skills. Besides, they concluded that it is a viable strategy for the non-communicable diseases unit within the Ministry of Health. In Ethiopia, fewer than 50% of diabetic individuals obtain proper diabetes care.
Despite the empirical studies showing positive and significant relationships between diabetes peer support and treatment adherence among patients with diabetes, the exact mechanism by which peer support affects patient adherence is not yet completely understood. Further research is needed to address how the differences in types of support, such as functional or emotional support, are linked to outcomes for patients. Specifically, there remains a gap in understanding what constitutes peer support and how to effectively implement it in low-resource environments, like Ethiopia health care settings.
Patient education materials provided by diabetes focused organizations do not increase patient self efficacy or engagement with self management as these documents contain complex medical jargon and provide only general guidelines, not patient-specific instruction. Peer support interventions, where individuals with lived experience of diabetes share advice, encouragement, and practical strategies, offer a potentially powerful extension of these existing support systems. Such programs have demonstrated benefits in enhancing treatment adherence, self-care practices, and disease-related knowledge in various settings. Despite this, there is limited data from Ethiopia on the effect of structured peer support groups among patients receiving care in tertiary hospitals.
This study assesses the effectiveness of a structured peer support group in enhancing medication adherence, self-care behaviors, and diabetes-related knowledge among adult patients attending follow-up at ACSH, a tertiary care facility in northern Ethiopia. The findings aim to inform efforts to integrate peer support into routine diabetes care within similar low-resource environments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Structured Diabetes Education on medication Adherence and self careParticipants receive peer-led support sessions in addition to usual diabetes care. |
| No-Intervention Comparator: Standard Care Alone(Control group) | No intervention | –Participants continue with routine follow-up and standard diabetes care only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Diabetes Education on medication Adherence and self careAlso: Structured Diabetes Education on Diabetes definition, sign and symptoms and managementLived-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. | Behavioural | Intervention Group |
Primary outcome
Medication Adherence Status
Time frame: Baseline and 6 months
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).
Overall Diabetes Self-Care Practice Score
Time frame: Baseline and 6 months
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.
Diabetes Knowledge Status
Time frame: Baseline and 6 months
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
1 secondary outcome
Medication Adherence Status by Pill Count
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35914061Magliano 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/
- Background: PubMed 28688818Atun 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.
- Background: PubMed 31454396Gebreyohannes 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.
- Background: PubMed 28702258Fisher 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.
- Background: PubMed 19509083Funnell 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.
- Background: PubMed 34696569Azmiardi 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.
- Background: PubMed 30569831Gutierrez 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.
- Background: PubMed 29357380Debussche 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.
- Background: PubMed 32858474Khare 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.
- Background: PubMed 30652911Lee 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.
- Background: PubMed 36376960Shiyanbola 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.
- Background: PubMed 28801473Edelman 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.
- World Health Organization. Adherence to long-term therapies: evidence for action.Link provided by the sponsor.
- Book chapter on assessing diabetes self-management summary diabetes self-care activities questionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: No. Currently, our data needs clearance,organization and documentation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halefom K Haile, Msc principal investigator
Addis Ababa University, Adigrat university
Teferi G Fenta, Professor study chair
Addis Ababa University
Bruck M Habte, PhD study director
Addis Ababa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Diabetes Education on medication Adherence and self care in people with Peer Influence and Medication Adherence, run by Addis Ababa University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Status (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145983, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.