Medication Adherence, Peer Influence, Self Care
Conditions
Keywords
Diabetes Mullites, Peer support, Medication adherence, self-care Practice, Diabetes Knowledge
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.
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.
Interventions
BEHAVIORALStructured Diabetes Education on medication Adherence and self care
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.
Sponsors
Addis Ababa University
Mekelle University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Status | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Status by Pill Count | Baseline and 6 months | 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. |
Countries
Ethiopia
Contacts
PRINCIPAL_INVESTIGATORHalefom K Haile, Msc
Addis Ababa University, Adigrat university
STUDY_CHAIRTeferi G Fenta, Professor
Addis Ababa University
STUDY_DIRECTORBruck M Habte, PhD
Addis Ababa University
Participant flow
Recruitment details
The study was conducted in two phases. Phase I was a preparatory phase involving recruitment and training of peer supporters and a nurse facilitator for intervention delivery. No trial participants were enrolled in Phase I. Phase II involved enrollment and randomization of eligible diabetic patients into intervention and control groups
Pre-assignment details
The study was conducted in two phases. Phase 1 was a preparatory phase conducted prior to participant enrollment and randomization. Phase 1 involved the recruitment and training of peer supporters (n = 5) and one registered nurse facilitator to support the delivery of the intervention. Individuals involved in Phase 1 were not trial participants, were not enrolled under the randomized clinical trial protocol, and did not contribute data to participant flow, baseline characteristics, outcome measu
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 17.1 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 31 Participants |
| Type of Diabetes Mullituse Type 1 Diabetes Mullites (T1DM) | 52 Participants |
| Type of Diabetes Mullituse Type 2 Diabetes Mullites(T2DM) | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 2 / 50 | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
None listed