Trial Outcomes & Findings for Effect of Peer Support Intervention on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes (NCT NCT07145983)

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

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 were collected only from Phase 2 randomized trial participants. No baseline data were collected from individuals involved in the Phase 1 preparatory activities.

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 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-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

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.