Abstract
BACKGROUND: Chronic kidney disease of uncertain etiology (CKDu) is chronic kidney disease (CKD) where etiology is uncertain. CKDu is predominant among farmers in North Central Province (NCP), Sri Lanka. CKD remains asymptomatic until advanced stages. As disease progresses, patients experience comorbidities (anemia, bone mineral disorder, cardiovascular complications). Increasing medication burden contributes to challenges in medication adherence. Several factors cause impairments and reduce quality of life (QOL). Studies assessing clinical pharmacy services on medication adherence and QOL among CKDu patients are scarce. This study evaluated impact of clinical pharmacy services on medication adherence and QOL among CKDu outpatients at a tertiary hospital in NCP, Sri Lanka. METHODS: A randomized controlled trial was conducted in pre-dialysis renal clinics, enrolling patients diagnosed with CKDu stages 4 or 5. Sealed envelope technique was used to randomize participants to control group (CG) or intervention group (IG). IG received standard care plus four counselling sessions by the clinical pharmacist. Medication name, dose, frequency, and side effects were counselled over 12 months (at recruitment, two, six and ten months). CG received standard care. Demographics were collected at recruitment. Self-reported medication adherence and QOL were assessed at baseline and after 12 months using Brief Medication Questionnaire (BMQ) [Median, Inter Quartile Range (IQR)] and Kidney Disease Quality of Life-Short Form (KDQOL-SF), [Mean, Standard Deviation (SD)] respectively. Three summary QOL scores were calculated: Kidney Disease Component Summary (KDCS), Physical Component Summary (PCS), and Mental Component Summary (MCS). Mann-Whitney U test and independent samples t-test were used in analysis. RESULTS: Of 252 participants, 196 completed study (CG = 99,IG = 97). Total BMQ scores were significantly lower in IG (3 [2-4]) compared to CG (5 [4-5])(p < 0.001), indicating better medication adherence. Three QOL scores were higher in IG: KDCS 79.35(± 9.20) vs. 70.90 (± 12.60)(p < 0.001), PCS 67.92(± 18.42) vs. 47.39(± 19.73)(p < 0.001), and MCS 88.52 (± 16.67) vs. 80.07(± 16.77)(p = 0.001). CONCLUSIONS: Intervention significantly enhanced medication adherence and QOL among pre-dialysis patients with CKDu, demonstrating the positive impact of added clinical pharmacy services to existing healthcare team in managing CKD patients. TRIAL REGISTRATION: The trial was prospectively registered in the Sri Lanka Clinical Trials Registry on 16th of December 2015. Trial registration number was SLCTR/2015/030. ( https://slctr.lk/trials/slctr-2015-030 ).