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Peer Support InterventionPSINCT07499375

Effect of a Peer Support Intervention on Glycemic Control and Economic Burden Among Patients With Diabetes

A study testing Peer led educational intervention program in people with Peer Support Intervention, run by Addis Ababa University at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Diabetes imposes a growing global burden due to rising care costs and reduced quality of life from its complications. Managing the disease remains challenging for many patients, highlighting the need for effective, scalable support strategies. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Peer Support Intervention
What is being tested?
Peer led educational intervention program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEthiopia
Study dates
1 Dec 2024to 30 Aug 2025
Phase
Interventional

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
  • Healthy volunteers accepted
  • 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 comprehencive Specialized Hospital(University Hospital)

    Mek'ele, Tigray, 50

Other trials in Ethiopia

About this study

Official title: Effect of a Peer Support Intervention on Glycemic Control and Economic Burden Among Patients With Diabetes on Follow-up at a Tertiary Hospital: A Randomized Controlled Trial

Diabetes imposes a growing global burden due to rising care costs and reduced quality of life from its complications. Managing the disease remains challenging for many patients, highlighting the need for effective, scalable support strategies. Peer support has shown promise in improving diabetes self-management, yet evidence from randomized trials in Ethiopia, particularly on both clinical and economic outcomes, is limited. Thus, this study aimed to evaluated the effect of a peer support intervention on glycemic control and economic burden among patients with diabetes.

Read the detailed description

Globally, diabetes poses a growing challenge for health systems and communities, largely due to escalating care costs and the decline in quality of life associated with its chronic complications. Regardless of therapeutic advancements, managing diabetes to achieve strict glycemic control over the long term is still difficult long term basis remains complicated and ponderous, which in case of failure leads to inadvertently poor cardiovascular and microvascular outcomes. A healthy lifestyle, appropriate diet, and medication adherences among diabetic patients are essential factors to the prevention of diabetic complications as well as maintain good glycemic control. However, many patients with diabetes fail to prevent diabetes due to the complex nature of the disease and its management. Hence, patients with diabetes need self-management education to assist them in comprehending and dealing with the disease. Peer support is considered a promising, feasible, and culturally appropriate enhancement to diabetes care which recently has been found as a potential resource for diabetes self-management. It is effective for preventing the complications of diabetes and enhancing health outcomes in patients with diabetes.

Despite advances in therapy, achievement of glycemic targets remains an unmet need in a substantial proportion of patients with diabetes. According to reports from the healthcare effectiveness data and information set in United States of Amarica (USA), Hemoglobin A1C(HbA1C) <7.0% (53 mmol/mol) is only reached by roughly 40% commercially insured populations and 30% of diabetic individuals in the Medicaid. These figures suggest that despite advanced treatments, many individuals struggle to meet their glycemic targets. The clinical effectiveness of peer support in improving glycemic control has been supported by ubiquitous research findings. A meta-analysis of 13 randomized controlled trials found that peer support interventions reduce HbA1c by a mean of -0.57% (95% CI -0.78 to -0.36) compared to usual care. Importantly, the benefit was greater in interventions with moderate or high contact intensity, whereas low frequency programs showed no significant effect.Another meta-analysis of 17 studies showed a smaller but still significant HbA1c improvement of approximately 0.24% (95% CI 0.05-0.43) in peer support groups versus controls.

These findings underline both the potential and the variability in the efficacy of peer-support strategies in diabetes care. Similarly , a study conducted in Uganda showed that improvements of HbA1c level, 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. In Ethiopia, fewer than 50% of diabetic individuals obtain proper diabetes care . The lack of access to diabetes education and blood glucose monitoring in the nation results in insufficient control of hyperglycemia, which is frequently linked to poverty and treatment discontinuation for a variety of social and economic reasons. About 95% of patients with diabetes mellitus do not self-monitor their blood glucose levels at home, 33% do not consistently take their medications, and 75% need to be admitted to the hospital either directly or indirectly as a result of uncontrolled diabetes. To encourage diabetes self-management, an intensive one-to-one session led by physicians, dieticians, and social workers was delivered and found effective in a variety of health care settings. However, such approaches are difficult to scale in routine care within low and middle income countries (LMICs), where diabetes is highly prevalent and the supply of specialized health professionals is limited. In these settings, peer support offers a practical option to help individuals adopt and maintain healthier behaviors and addressing the burden of diabetes.

In addition to clinical benefits, any decision regarding the adoption of a healthcare program in a resource constrained health system will depend upon its expected economic implications that is, on whether it generates improvements in patients' health at an acceptable cost. Diabetes puts a significant financial burden on patients in Ethiopia and other low-resource settings because of high out-of-pocket costs, insufficient insurance coverage, and the high cost of necessary medical care. A cross-sectional study in the Southwest Shewa Zone found that the mean monthly cost of diabetes care was USD 37.7, with direct costs accounting for over 75% of the total burden. Another study in Addis Ababa reported a median direct monthly cost of USD 21.8 per diabetes patient, as well as significant productivity losses by patients and caregivers. These financial pressures limit access to consistent diabetes care and may worsen its complication. While cost-benefit analyses of peer support intervention have been under-reported in many health care settings, some data suggested that it can reduce costs. International evidences like the United kindome-based randomized controlled trial found the annual implementation cost of peer support per participant was only £13.84 and concluded that providing peer support intervention for patients with diabetes has a benefit not only improved clinical outcomes but also generated net cost savings by decreasing the amount of healthcare services used per participant. Similarly, a trial from Austria found that group-based peer support participants were hospitalized for a shorter duration than controls, which resulted in a cost savings of approximately €1,660 per patient during the first two years of treatment. Given these findings, peer support appears to be a potentially cost-saving, scalable approach.

Although the positive findings from these studies are promising, there have been limited numbers of randomized controlled trials that evaluate the effects of peer support on both the clinical outcome and its comprehensive economic feasibility on patients with diabetes. The relevance of understanding how peer support positively affects patients' direct economic burdens is not just those associated with the health care delivery systems but it has special significance for LMICs, in which out-of-pocket expenditures represent a major impediment to receiving medical care. As to the effect of peer support on glycemic control, there have been many studies on the relation between peer support and glycemic control effect among patients with diabetes but the results of different trials have not been altogether consistent. Additionally, there is no guideline for the implementation of peer support specifically in low-resource environments, like Ethiopia health care settings. Therefore, this study reports the effects of peer support educational intervention on glycemic control and its economic implications on patients with diabetes.

Being tested
Peer led educational intervention program
Keywords
peer Led Intervention, DM, Glycemic Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer led educational intervention programBehavioural

    Structured Diabetes Education on Diabetes definition, sign and symptoms and management

Study groups in NCT07499375
Study groupRoleWhat they receive
Intervention GroupActive comparatorParticipants receive peer-led support sessions in addition to usual diabetes care.Behavioral: Structured Diabetes Education on Glycemic control 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. Other Names: • Structured Diabetes Education on Diabetes definition, sign and symptoms and management
Receives: Behavioral: Peer led educational intervention program
Control GroupNo interventionStandard Care Alone(Control group) 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.

  1. Glycemic control

    Measured using HbA1c change between the groups

    Measured: Baseline and 6 months

Secondary outcomes (1)
  1. peer support Implmentation cost

    Evaluating the cost expensed for the implementation of peer support program for the consecutive three rounds

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start1 Dec 2024
  3. Primary completion30 Jul 2025
  4. Study completion30 Aug 2025

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499375
Sponsor's protocol ID
AAU-SoP
Other IDs
084/24/SoP
Acronym
PSI
Status last verified
Mar 2026
First submitted
24 Mar 2026
Last updated
6 Apr 2026
Results posted
No
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

  • Gagliardino JJ, Arrechea V, Assad D, Gagliardino GG, Gonzalez L, Lucero S, Rizzuti L, Zufriategui Z, Clark C Jr. Type 2 diabetes patients educated by other patients perform at least as well as patients trained by professionals. Diabetes Metab Res Rev. 2013 Feb;29(2):152-60. doi: 10.1002/dmrr.2368. Epub 2013 Jan 3.

    PubMed 23166062
  • Kitabchi AE, Freire AX, Umpierrez GE. Evidence for strict inpatient blood glucose control: time to revise glycemic goals in hospitalized patients. Metabolism. 2008 Jan;57(1):116-20. doi: 10.1016/j.metabol.2007.08.014.

    PubMed 18078868
  • Zoungas S, Chalmers J, Ninomiya T, Li Q, Cooper ME, Colagiuri S, Fulcher G, de Galan BE, Harrap S, Hamet P, Heller S, MacMahon S, Marre M, Poulter N, Travert F, Patel A, Neal B, Woodward M; ADVANCE Collaborative Group. Association of HbA1c levels with vascular complications and death in patients with type 2 diabetes: evidence of glycaemic thresholds. Diabetologia. 2012 Mar;55(3):636-43. doi: 10.1007/s00125-011-2404-1. Epub 2011 Dec 21.

    PubMed 22186981
  • 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.

    PubMed 34696569
  • 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.

    PubMed 32858474
  • 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.

    PubMed 30652911
  • 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.

    PubMed 19509083
  • Lynch CP, Egede LE. Optimizing diabetes self-care in low literacy and minority populations--problem-solving, empowerment, peer support and technology-based approaches. J Gen Intern Med. 2011 Sep;26(9):953-5. doi: 10.1007/s11606-011-1759-9. No abstract available.

    PubMed 21647745
  • Stark Casagrande S, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013 Aug;36(8):2271-9. doi: 10.2337/dc12-2258. Epub 2013 Feb 15.

    PubMed 23418368
  • Qi L, Liu Q, Qi X, Wu N, Tang W, Xiong H. Effectiveness of peer support for improving glycaemic control in patients with type 2 diabetes: a meta-analysis of randomized controlled trials. BMC Public Health. 2015 May 6;15:471. doi: 10.1186/s12889-015-1798-y.

    PubMed 25943398
  • Dale JR, Williams SM, Bowyer V. What is the effect of peer support on diabetes outcomes in adults? A systematic review. Diabet Med. 2012 Nov;29(11):1361-77. doi: 10.1111/j.1464-5491.2012.03749.x.

    PubMed 22804713
  • Baumann LC, Frederick N, Betty N, Jospehine E, Agatha N. A demonstration of peer support for Ugandan adults with type 2 diabetes. Int J Behav Med. 2015 Jun;22(3):374-83. doi: 10.1007/s12529-014-9412-8.

    PubMed 24733698

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