Bridging the Adherence Gap: Innovative Counseling Strategies and their Effect on HbA1c in Type 2 Diabetes Patients

Medication adherence is “the degree to which a person’s behavior corresponds with agreed-upon recommendations from a healthcare provider” (Parmaret al., 2025). However, over 50% of Type 2 Diabetes mellitus (T2DM) patients worldwide fail to take their prescribed medications, a problem that more prevalent in nations with low or middle incomes, where T2DM accounts for over 95% of cases (Sendekie et al., 2022). Non-adherence levels in India may exceed 50% due to high medication costs, a lack of knowledge, polypharmacy, side effects, and sociocultural beliefs (Yosef et al., 2023). Diabetes Mellitus (DM) is a widespread health concern, with an estimated 783 million cases projected by 2045 (International Diabetes Federation, 2024).

Diabetes therapy aims to achieve optimal glucose control to avoid complications such as cardiovascular disease, nephropathy, neuropathy, and retinopathy (Afayaet al., 2020). Non-adherence remains a major challenge, resulting in treatment failure, increased hospitalizations, and greater mortality and morbidity rates (Stewart et al., 2022). Older age, longer diabetes duration, financial restrictions, and educational background are associated with medication adherence (Huanget al., 2021). Adherence has a major influence on metabolic management, and understanding the factors that influence nonadherence is essential for improving outcomes (Verma et al., 2024). Simple strategies, including smartphone reminders and pillboxes, can enhance adherence. Clinical pharmacist-led counseling improves adherence by educating patients leading to better outcomes (Worrall et al., 2024).

This study aimed to assess medication adherence patterns among T2DM patients, identify factors contributing to non-adherence, and better understand the reasons behind low adherence. It also evaluates the impact of pharmacist-led patient counseling on improving adherence and emphasizes its significance.

The 12-month prospective observational study included T2DM patients from a tertiary care hospital’s General Medicine and Endocrinology departments who complied with institutional norms.

The study initially enrolled 200 participants, with 186 completing the first follow-up after one month. After three months, the number reduced to 161 due to issues such as unavailability and non-responsiveness. These participants were considered in the final analysis.

We included newly diagnosed T2DM patients aged 18-59, either of gender, on an antidiabetic regimen, and with at least one comorbidity. The study only included patients who provided informed consent and an in-depth explanation. The study excluded patients with type 1 diabetes, gestational diabetes, hospitalization, and major concomitant conditions such as End-Stage Liver Disease (ESLD), End-Stage Renal Disease (ESRD), malignancy, post-transplant diabetes, or recent cardiac events.

Details on the patient’s age, gender, educational background, employment, marital status, and social history were documented.

Patient data includes medical and medication history, family history, and diabetes duration (<5, 5-10, or >10 years). HbA_1c levels were used to assess glycemic management in three categories: 6.5-7.0%, 7.1-10%, and >10%. Complications related to diabetes were documented.

Medication adherence was evaluated using the 8-item Morisky Medication Adherence Scale (MMAS-8), which coordinates subjective self-reports with objective data to provide reliable adherence evaluation. The MMAS-8 was translated into Marathi utilizing a rigorous forward-backward procedure to assure its precision and clarity, with bilingual experts reviewing both versions to preserve the scale’s original meaning.

The MMAS-8 includes eight questions intended specifically to assess medication adherence. It consists of seven “yes/no” questions and one 5-point Likert scale item. The Score depends on response accuracy: most questions award one point for each accurate response, except of question 5, where a “No” answer obtains one point. A “never/rarely” response receives 0 points on the Likert-scale questions, whereas other replies score one point for each. Adherence is divided into three categories: low (≥2 points), medium (1-2 points), and high (0 points).

The 15-item Medication Adherence Reasons Scale (MARS-15), which evaluates causes for medication non-adherence across five domains: Management Issues, Multiple Medication Concerns, Belief Issues, Availability Issues, and Forgetfulness/Inconvenience. To ensure linguistic authenticity, the scale was translated into Marathi using the same rigorous forward-backward procedure used for MMAS-8. This technique highlights specific factors to adherence, allowing for better management plans.

The leaflet effectively counsels patients regarding medication adherence, addressing common issues like forgetfulness, side effect concerns, medication costs, and the difficulties of managing polypharmacy. Patients were counseled on practical strategies such as using pill boxes, setting reminders, reaching out to healthcare providers for prescription issues, and asking their healthcare team before changing or discontinuing their medications. The leaflet aimed to improve medication adherence and provide practical advice, which was then distributed to patients after counseling.

Initially, after obtaining consent, we conducted a 10-15 min interview with patients to collect their demographic, clinical, and HbA_1c values, along with details about their glucose-lowering therapy. Participants were categorized based on low, medium, or high medication adherence using the MMAS-8 scale. The MARS-15 scale determined non-adherence factors in the low and medium adherence categories. All patients received verbal counseling along with a leaflet featuring adherence suggestions. A one-month follow-up via phone call or in-person interview evaluated MMAS-8 and advised patients to check their HbA_1c levels before the next follow-up. At the final three-month follow-up, the MMAS-8 questionnaire was re-administered to assess medication adherence patterns, and HbA_1c levels were recorded again to compare with the initial values to evaluate the impact of counseling, followed by data analysis.

The data was collected using Google Forms and analyzed using Microsoft Excel 2013. A paired t-test was used to compare mean values from three phases: initial, first follow-up, and second follow-up, and also compare initial and final HbA_1c values. A p-value <0.05 was considered statistically significant.

The Institutional Ethics Committee approved the study (DMHRC Code: PharmD_2023_NJ_14, dated 03-11-2023). The study follows the Helsinki Declaration’s guidelines.

The evaluation of 161 patients revealed a predominance of males, 103 (63.97%). A majority of patients were 46-59 years old, 127 (78.88%). Regarding risk factors, 18 (11.18%) consumed alcohol, and 6 (3.72%) were smokers. The majority of patients, 156 (96.89%), were married, with 108 (67.08%) being graduates and 118 (73.29%) employed, see Table 1.

Diabetes duration varied across individuals, with 65 (40.37%) having it for 5-10 years, 52 (32.30%) for <5 years, and 44 (27.33%) for >10 years. Hypertension was the most common comorbidity among T2DM patients, accounting for 60 (37.27%), see Table 2.

87 (54.04%) individuals had a positive family history of T2DM, whereas 74 (45.96%) had no such history. There were 27 complications, with neuropathy becoming the most prevalent 13 (8.07%), followed by retinopathy 6 (3.72%) and nephropathy 4 (2.48%), demonstrating a widespread prevalence of neuropathy, see Table 3.

According to the treatment profile, most patients received Oral Hypoglycemic medications (OHA) alone, followed by insulin therapy separately, and combined OHA and insulin as shown in Figure 1.

Figure 1:
Treatment Profile.

Medication adherence was assessed utilizing MMAS-8 in three stages: initially (before counseling), at the first follow-up (after counseling), and the second follow-up. Initially, 90 (55.90%) were low adherent, 32 (19.87%) were medium adherent, and 39 (24.22%) were high adherent. Following the first counseling, low adherence dropped to 58 (36.02%), medium adherence increased to 47 (29.19%), and high adherence increased to 56 (34.78%). By the second follow-up, poor adherence had dropped to 38 (23.60%), medium adherence to 50 (31.05%), and high adherence had risen to 73 (45.34%) as shown in Figure 2.

Figure 2:
Adherence measurement.

The mean adherence score increased considerably from the initial phase (1.654±0.709) to the first follow-up (1.931±0.718, p<0.001), followed by the second follow-up (2.037±0.707, p<0.001). The statistically significant improvement (p=0.021) between the first and second follow-ups demonstrates that the positive benefits of adherence were sustained after post-counseling, see Table 4.

In terms of individual behaviors, 77 (47.77%) reported forgetting to take their medication when traveling, which improved to 51 (31.68%) at the first follow-up but significantly increased to 58 (36.02%) at the second. Initially, 96 (59.75%) felt that taking medicine every day was a real inconvenience, which dropped to 72 (44.72%) at the first follow-up and rose to 77 (47.83%) at the second. Furthermore, 58 (36.04%) discontinued taking medicine when symptoms were under control, which decreased to 46 (28.57%) at the first follow-up and 45 (27.95%) at the second. Furthermore, 34 (21.12%) admitted to forgetting to take their medication, which improved to 33 (20.50%) at the first follow-up and 30 (18.63%) at the second, indicating an improving pattern in adherence, see Table 5.

The MARS-15 identified factors that contribute to non-adherence. Management issues include uncertainty over administration of 32 (7.32%) patients. Patients also expressed concerns regarding the long-term effects in 38 (8.69%) patients. Fears of side effects 39 (8.92%) patients were included among the belief-related issues. Patients highlighted availability concerns due to busy schedules 32 (7.32%) patients. The predominant issue was forgetfulness, affecting 89 (20.36%) patients, see Table 6.

During the initial interview, 99 (61.49%) had moderately raised HbA_1c (7.1%-10%), 41 (25.47%) had effectively managed diabetes (6.5%-7.0%), and 21 (13.04%) had poorly managed diabetes (HbA_1c>10%). At the three-month follow-up, 20 (12.42%) had poorly managed diabetes (HbA_1c>10%), 6 (3.72%) had well-controlled glucose (HbA_1c 5.7%-6.4%), 51 (31.67%) maintained excellent glucose control (HbA_1c 6.5%-7.0%), and 84 (52.17%) had moderately increased (HbA_1c 7.1%-10%), indicating improvement in glycemic control.

A t-test comparing the beginning and final HbA_1c values revealed a t-statistic value of 3.93 and a p-value of 0.0001, indicating a statistically significant decrease in HbA_1c levels post-counseling, confirming that the observed improvement is not due to random variation. The positive t-statistic indicates a general decrease in HbA_1c values, demonstrating overall improvements.

This study revealed a male predominance, consistent with studies emphasizing that males had more significant diabetes rates (Mnifet al., 2022). The majority of patients were adults from age 46 to 59, which is similar to Diabetes Control and Complications Trial (DCCT) findings highlighting older people suffer from greater diabetes complication risks (ElSayedet al., 2023). Majorly participants had diabetes for 5-10 years, which has been linked to increased complications due to a reduction in medication adherence (Olickalet al., 2021). In this study, lifestyle factors such as social habits had a substantial impact on diabetes control (Sahoo et al., 2022). The majority of patients had spouses, which has been associated with increased adherence as a result of partner support (Otanga et al., 2022). Higher levels of education can increase health literacy, which is necessary for understanding diabetes treatment plans and adhering to prescription regimens effectively (Diabetesjournals.org, 2024). Stable employment improves diabetes management by ensuring access to healthcare, medications, and health insurance, while unemployed individuals may face financial constraints, emphasizing the importance of socioeconomic factors in diabetes care and adherence. (Helleboet al., 2024).

Hypertension, a prevalent comorbidity in T2DM, affects 37.27% of patients. A similar study found that hypertension affects roughly 39.5% of T2DM patients. The high prevalence emphasizes the significance of managing both illnesses concurrently to optimize patient outcomes (Haile et al., 2022). Lipid disorders and CKD are common comorbidities in T2DM patients, displaying the significance of integrated medication to reduce health risks and improve outcomes (Zhang et al., 2022). A family history of diabetes had a substantial impact on the study findings, underlining genetic and lifestyle factors as major factors in T2DM risk (Vassou et al., 2023). Diabetic neuropathy is the most prevalent comorbidity (48.1%), similar to a study revealing that it affects almost half of all T2DM patients. The findings also emphasized diabetic retinopathy and nephropathy. Regular screenings, comprehensive treatment strategies, and family history consideration are essential for patient risk assessment and care planning. (Basebaaet al., 2024). Patients receiving combined insulin and OHA treatment were at more risk of uncontrolled hyperglycemia (Rajanet al., 2024).

Counseling significantly improves medication adherence by reducing low and high adherence. Key barriers like forgetfulness while traveling and difficulty sticking to their medication every day were reduced post-counseling but slightly increased during the second follow-up. This highlights the importance of ongoing patient education and follow-up for long-term adherence. (Carratalá-Munueraet al., 2022). Following counseling, there was a significant improvement in adherence (p<0.001), which continued at the second follow-up (p=0.021). A similar study found that structured counseling interventions dramatically improved long-term medication adherence in diabetic patients (Atolagbeet al., 2023).

Additionally, concerns about long-term effects, medication costs, and availability further impacted adherence. These findings underscore the need for strategies that address both psychological factors (e.g., fear of side effects) and practical challenges (e.g., forgetfulness, cost), including enhanced patient education, simplified treatment regimens, and financial support to improve medication adherence (Kalamanet al., 2024).

This study demonstrated that leaflet distribution and verbal counseling significantly improved glycemic control in T2DM patients, as evidenced by reduced HbA_1c values after three months. Most patients had moderately elevated HbA_1c at baseline, although there was a noticeable change toward better glycemic control following counseling. A paired t-test yielded a t-statistic of 3.93 and a p-value of 0.0001, indicating a significant drop in HbA_1c levels post-counseling. The study found that patient education, such as verbal counseling and leaflets, significantly improved glycemic control, pointing out the importance of effective diabetes management and optimizing patient outcomes (Thanh & Tien, 2021).

The study investigated medication adherence patterns and found that verbal patient counseling significantly improved glycemic control and medication adherence in individuals with T2DM when supported by leaflet distribution. Education and follow-ups overcome the barriers influencing non-adherence. The study concluded that addressing socioeconomic variables, including education, can further enhance adherence. The study indicates the positive impacts of measures on glycemic control and HbA_1c levels, highlighting the need for ongoing patient-centered support in overcoming physical and psychological barriers to better diabetes management.