A Community Pharmacy-Based Intervention in the Matrix of Type 2 Diabetes Mellitus Outcomes (CPBI-T2DM): A Cluster Randomized Controlled Trial

Abstract

Introduction: Egypt has the ninth highest diabetes mellitus (DM) prevalence in the world. There is a growing interest in community involvement in DM management. Aim of the study: The aim of the study was to evaluate the tailored diabetes care model (DCM) implementation in Alexandria governorate by community pharmacy-based intervention (CPBI) from a clinical, humanistic, and economic aspect. Methods: This is a 6-month period cross-over cluster randomized control trial conducted in Alexandria. Ten clusters owing 10 community pharmacies (CPs) recruited 100 health insurance-deprived T2DM patients with >7% HbA1c in 6-months. The study was divided into 2 phases (3 months for each period) with a 1-month washout period in between. After CPs training on DCM, the interventional group received pictorial training for 45 minutes in first visit, and 15 minutes in weekly visits, whereas the control group patients received the usual care (UC). At baseline and end of each phase (3 months), patients had clinical and physical activity assessments, filled all forms of study questionnaire (knowledge, self-management, satisfaction, and adherence) and did all laboratory investigations (Fasting Blood Glucose [FBG]), HbA1c, protein-creatinine clearance (PCR), creatine clearance (GFR), and lipid profile. Results: There was no significant difference in the basal systolic and diastolic blood pressure between patients in the CBPI and UC groups, but the CBPI had significantly decreased the mean SBP and DBP by ( P = .008, .040, respectively). Also, significant waist circumference and BMI reductions (−5.82 cm and −1.86 kg/m 2 , P = .001) were observed in the CBPI. The CBPI patients achieved a greater reduction in FBG and HbA1C than the UC patients (102 mg/dL and 1.9%, respectively P < .001). Also, significant reductions in total cholesterol, LDL, and triglyceride (−6.4, −15.4, and −6.3 mg/dL respectively, P = .001) were achieved in the CBPI group. No significant differences were found in HDL, GFR, and PCR. Moreover, significant improvements of behavior, score of knowledge, self-management, satisfaction, and adherence were observed in CBPI patients. After multivariate analysis, HbA1C readings were significantly influenced by baseline HbA1C and eating habits. The cost saving for CPBI was −1581 LE per 1% HbA1c reduction. Conclusion: This is the first study in Egypt that illustrated the positive impact of pictorial DCM delivered by CPBI collaborative care on clinical, humanistic, laboratory, and economic outcomes to local T2DM patients.