Multidimensional associations of HbA1c with behavioural, psychosocial, and economic factors across Educational Pharmaceutical Care Interventional Program (EPCIP) timeline: a prospective, longitudinal, RCT study.
TL;DR
Stronger longitudinal HbA1c correlations and increased MMAS scores demonstrated the significant improvements in glycaemic stability and behavioural adherence brought about by the EPCIP intervention, confirming its validity as a patient-centred approach to long-term diabetes care.
Abstract
INTRODUCTION According to real-time data from Gujarat, which has the third highest score in the country nationally (7.55%), shows that behavioral, psychological, and economic stressors are associated with elevating HbA1c levels. The current investigation of multifaceted connection within the educational pharmaceutical care interventional program (EPCIP) timeline provides important information about regional causes of inadequate glycaemic control and aids in the development of tailored diabetes management strategies.
Objective
The primary objective of this study was to examine the association between longitudinal variations in HbA1c and a structured hospital-based EPCIP delivered by clinical pharmacists. In addition, secondary objective was focused on behavioral, medication adherence, psychological, and economic characteristics of patients in the control group (n = 139) and intervention group (n = 141) across five visits conducted in Gujarat, India. METHODOLOGY A randomized, parallel‑group trial was conducted at the Saarathi Institute of Diabetes Sciences, Anand, India, enrolling 280 patients with type 2 diabetes mellitus aged 18-75 years. Eligible participants (HbA1c > 7%, on oral hypoglycemic agents and/or insulin therapy) were recruited and allocated into control (n = 139) and intervention (n = 141) groups using adaptive randomization minimization. The intervention comprised a structured patient‑education framework focusing on self‑management and adherence. Over a 16‑month period (64 weeks), patients in the intervention group attended one educational and one discussion session at each follow‑up (0, 4, 8, 12, and 16 months). Associations between HbA1c and behavioral outcomes (Knowledge, Attitude, Practice [KAP] questionnaire), adherence (Morisky Medication Adherence Scale [MMAS‑8]), psychosocial outcomes (Diabetes Distress Scale [DDS‑17], WHOQOL‑BREF), and economic outcomes (Cost of Illness Questionnaire [COIQ]) were analyzed using regression models to estimate linear relationships across visits between groups.
Results
The EPCIP intervention group showed progressively stronger longitudinal correlations in HbA1c stability (r = 0.74 to 0.89, p=0.000), surpassing the control group (r = 0.62 to 0.74). At Visit 5, significant correlations were observed between HbA1c and indirect cost (r = 0.160, p = 0.022), and medication adherence (MMAS: r = -0.243, p = < 0.001). Total KAP scores maintained consistent negative correlations (r = -0.042, p=0.030), while emotional (r = 0.141, p = 0.044) and physician-related distress (r = 0.593, p < 0.001) notably decreased. Regimen distress normalized (r = -0.019, p = 0.792). Quality of life scores improved post-intervention across physical (r = -0.078, p = 0.006), psychological (r = -0.033, p = 0.047), social (r = -0.047, p = 0.005), and environmental domains (r = -0.113, p = 0.001), indicating EPCIP's multidimensional impact.
Conclusion
Stronger longitudinal HbA1c correlations and increased MMAS scores demonstrated the significant improvements in glycaemic stability and behavioural adherence brought about by the EPCIP intervention. Multidimensional psychosocial improvement is reflected in the consistent inverse relationships between overall KAP and decreases in diabetes-related distress domains (DDS17). EPCIP's holistic impact is shown by post-intervention gains across WHOQOL-BREF domains, confirming its validity as a patient-centred approach to long-term diabetes care. CLINICAL TRIAL NUMBER Present clinical trial registered with clinical trial registry of India and national institute of medical statistics. CTRI NUMBER CTRI/2024/05/067435, Date of Registration:15/05/2024. URL: https://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1%26;compid=19%26;EncHid=12771.59772https://ctri.nic.in/Clinicaltrials/rmaindet.phptrialid=103273%26;EncHid=42604.82156%26;modid=1%26;compid=19.