- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07499375
Effect of a Peer Support Intervention on Glycemic Control and Economic Burden Among Patients With Diabetes (PSI)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Tigray
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Mek'ele, Tigray, Ethiopia, 50
- Ayder comprehencive Specialized Hospital(University Hospital)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Standard Care Alone(Control group) Participants continue with routine follow-up and standard diabetes care only.
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|
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Active Comparator: Intervention Group
Participants 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 |
Structured Diabetes Education on Diabetes definition, sign and symptoms and management
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic control
Time Frame: Baseline and 6 months
|
Measured using HbA1c change between the groups
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Baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
peer support Implmentation cost
Time Frame: 6 months
|
Evaluating the cost expensed for the implementation of peer support program for the consecutive three rounds
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Halefom Kahsay Haile, Msc, Addis Ababa University
- Study Director: Teferi G Fenta, Professor, Addis Ababa University
- Study Chair: Bruck M Habte, A. Professor, Addis Ababa University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAU-SoP
- 084/24/SoP (Other Identifier: Addis Ababa University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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