A Pharmacist-led Intervention to Support Type 2 Diabetes Self-Management in Community Pharmacy Settings of Pakistan

<p dir="ltr"><b>Background:</b> The increasing prevalence of Type 2 diabetes mellitus, along with the growing number of patients with poor glycaemic control, is a significant public health concern, especially for developing countries such as Pakistan. The surge in T2DM cases in Pakistan has put the current resource-deficient healthcare system under pressure, urging researchers to seek alternative approaches for better disease management and improved quality of life. There is evidence that self-management educational support can facilitate T2DM patients to assume an active and participatory role in their health, thereby enhancing disease-related outcomes. Community pharmacists (CPs) are vital in supporting T2DM self-management. However, their role in developing countries is underexplored, and there needs to be more evidence on the effectiveness of and normalisation of service in routine practice once it is implemented in Pakistan's community pharmacy settings. To fill this knowledge gap, this study was conducted in three phases. A systematic review of RCTs assessing the effectiveness of community pharmacist-led interventions on glycaemic control and self-management behaviours was conducted to inform study design. The objective of phase I was to map any association between T2DM self-management behaviours and clinical and psychosocial outcomes. Phase II aimed to implement and evaluate the CP-led diabetes self-management educational intervention program, and phase III examined the feasibility, acceptability, and sustainability of the intervention program in community pharmacy settings of Pakistan.</p><p dir="ltr"><b>Methods: </b>This was a multi-method study. Phase I was a cross-sectional study involving T2DM patients over 18 years old who could comprehend the Urdu language and were willing to participate. Participants were recruited from community pharmacies located in Lahore, Pakistan. Phase II was a pre- and post-interventional, quasi-experimental study without a control group. The diabetes self-management educational intervention was delivered by trained CPs practicing in community pharmacies in Lahore, Pakistan. The intervention was delivered via 04 face-to-face sessions and followed up through monthly telephone calls for 06 months. The effectiveness of the program was measured by changes in diabetes knowledge (DKQ), adherence to diabetes self-management behaviours (SDSCA), HbA1c level, patient-reported height and weight-based BMI, diabetes quality of life-brief clinical inventory (DQoL-BCI), and problem area in diabetes (PAID-5). The quantitative data of Phase I and Phase II were analysed using SPSS 27. Phase-III intervention program was further evaluated through semi-structured interviews with 20 participants (T2DM patients and CPs) who completed the phase-II. The questionnaire was used in both phases I and II. Phase I data were analysed using t-tests, one-way ANOVAs, and regression analyses. Phase II data were examined by paired-sample t-tests. In phase III, the audio-recorded interviews were professionally transcribed and thematically analysed.</p><p dir="ltr"><b>Results: </b>Phase I involved a cohort of 260 patients; most of them were male (54.6%), aged 41-60 years old (63.1%), and from low-income families (53.8%).</p><p dir="ltr">The mean HbA1c level was 7.96%, ranging from 6.2 to 12.3%, and most participants (78.8%) had poor glycaemic control. The participants had moderate diabetes-related knowledge, with a mean score of 13.6 (out of 24) and a standard deviation of 2.5. Most of the participants had mild to poor adherence to self-management behaviours, average quality of life, and high diabetes-related emotional distress. Regression analysis revealed that married individuals from high-income families with family support and high diabetes knowledge were more likely to adhere to T2DM self-management behaviours. We also found that for every unit, an increase in adherence to diabetes self-management behaviours (specific diet, medication adherence, general diet, and exercise) was significantly associated with a 1.26 to 1.43 times higher likelihood of having good glycaemic control and better quality of life. Similarly, higher adherence to general diet (OR = 0.71, 95% CI 0.56 – 0.89, p = 0.01), exercise (OR = 0.77, 95% CI 0.66 – 0.91, p = 0.01), medication uptake (OR = 0.73, 95% CI 0.61 – 0.86, p <.001) and foot care (OR = 0.67, 95% CI 0.29 – 0.86, p = 0.01) showed a statistically significant association with lower odds of having diabetes-related emotional distress. The analysis of endpoints of phase II revealed a substantial improvement in DKQ (p <.001), general diet (p <.001), specific diet (p <.001), foot care (p = 0.02), emotional distress (0.007), and diabetes-related quality of life (<.001). The post-study interviews highlighted that the program was feasible and acceptable for study participants. Convenient access to pharmacy, reduced treatment costs, and reduced doctor visits were the facilitators for patients’ uptake of the program. In contrast, lack of awareness about CPs’ role in diabetes management, logistic constraints, and social stigma were identified as potential barriers to the normalisation of the program. From the perspectives of CPs, lack of support from doctors and pharmacy owners, time constraints and workload pressure were the hurdles to embedding the program in their routine practice. Lastly, participants suggested a few adjustments in the intervention content and delivery.</p><p dir="ltr"><b>Conclusions:</b> The findings from the cross-sectional study revealed significant gaps in diabetes knowledge, self-management behaviours, and psycho-social outcomes which established a need for diabetes self-management educational intervention. The results of the experimental study highlighted that the intervention program effectively improved adherence to diabetes self-management behaviours and diabetes-related outcomes. Qualitative exploration from patients and pharmacists during Phase III confirmed the acceptability of the intervention and highlighted contextual factors that affect its sustainability and scalability. Overall, our findings offer a solid base to support the formal inclusion of pharmacists in managing chronic diseases in low-resource countries like Pakistan. Future research should focus on economic analyses and large-scale, randomised controlled trials to implement the program nationally.</p>