Clinical Pharmacist-Led Cardiovascular Risk Assessment in Patients With Chronic Kidney Disease (CRICKD) - NCT07927959
Sponsor: Marmara University Conditions: Chronic Kidney Disease (CKD), Cardiovascular (CV) Risk, Quality of Lifte, Medication Adherence Chronic kidney disease (CKD) is a long-term condition that can increase the risk of cardiovascular diseases, such as heart attacks and strokes. People with CKD often have other health conditions and take several medications, which can make following treatment plans challenging. Clinical pharmacists may help these patients by reviewing their medications, providing education, and supporting medication adherence and cardiovascular risk management. This study evaluated the impact of a clinical pharmacist-led pharmaceutical care program on cardiovascular risk, medication adherence, and quality of life in hospitalized adults with CKD. The study was conducted at a research and training hospital in Istanbul, Türkiye, with a planned six-month follow-up. A total of 150 patients were initially enrolled and assigned to either an intervention group or a control group. Due to deaths, withdrawal from the study, and loss to follow-up, 101 patients were included in the final analysis. Patients in the control group received standard medical care. Patients in the intervention group received additional pharmaceutical care from a clinical pharmacist, including medication review, education about CKD and cardiovascular risk factors, counseling on medication adherence and lifestyle changes, and follow-up counseling. The study assessed cardiovascular risk using a Framingham-based risk model. Medication adherence and health-related quality of life were evaluated using standardized questionnaires. Medication regimen complexity and relevant clinical measurements were also assessed. The findings showed that cardiovascular risk scores decreased in both groups during the study period. Medication adherence increased in both groups, from 59.2% to 75.5% in the control group and from 75.0% to 88.5% in the intervention group. However, the difference in medication adherence between the groups at follow-up was not statistically significant. Quality-of-life scores were significantly higher in the intervention group at both baseline and follow-up. A weak negative correlation was observed between medication regimen complexity and quality of life, indicating that greater medication complexity was associated with lower quality-of-life scores. Overall, the findings suggest that clinical pharmacist-led pharmaceutical care may support medication management in patients with CKD. However, the study did not demonstrate statistically significant differences between groups in medication adherence or cardiovascular risk outcomes. Further studies with larger samples and adequate follow-up are needed to clarify the effects of pharmacist-led interventions in this population. Chronic kidney disease (CKD) is a long-term condition associated with an increased risk of cardiovascular disease (CVD), including myocardial infarction and stroke. Cardiovascular risk in patients with CKD may be influenced by traditional risk factors, such as hypertension, diabetes mellitus, dyslipidaemia, smoking, and obesity, as well as by the clinical complexity associated with impaired kidney function and its treatment. Patients with CKD frequently have multiple comorbidities and require several medications, which may increase medication regimen complexity and create challenges for medication adherence and the management of cardiovascular risk factors. Clinical pharmacists can contribute to the multidisciplinary care of patients with CKD by reviewing medication regimens, identifying medication-related problems, providing patient education, and supporting adherence to prescribed treatments and recommended lifestyle changes. However, the effects of integrating clinical pharmacist-led pharmaceutical care into the management of cardiovascular risk, medication adherence, and health-related quality of life among hospitalised patients with CKD require further evaluation. This study evaluated a clinical pharmacist-led pharmaceutical care programme for hospitalised adults with CKD in the internal medicine clinic of a research and training hospital in Istanbul, Türkiye. The study used a controlled design with a six-month follow-up period. Patients in the intervention group received pharmaceutical care in addition to standard medical care, whereas patients in the control group received standard medical care. The pharmaceutical care intervention was designed to support medication management and improve patients' understanding of CKD and cardiovascular risk factors. The clinical pharmacist reviewed patients' medication regimens and provided individualised education concerning CKD, cardiovascular risk factors, the importance of medication adherence, and lifestyle modifications. Educational and counselling activities addressed relevant lifestyle factors, including dietary recommendations and smoking cessation. Patients interested in stopping smoking were informed about the smoking cessation support services available through the Turkish Ministry of Health. Follow-up counselling was provided during the study period to reinforce educational messages and support the management of medication-related concerns. The study assessed cardiovascular risk using a Framingham-based risk assessment model. Medication adherence was evaluated using the four-item Morisky-Green-Levine Medication Adherence Scale, and health-related quality of life was assessed using the 12-item Short Form Health Survey (SF-12). Medication regimen complexity was evaluated using the Medication Regimen Complexity Index (MRCI). Relevant clinical characteristics and measurements, including blood pressure, kidney function, lipid profile, and hospitalisation, were also considered in evaluating patients' clinical status during follow-up. The study aimed to determine whether the addition of clinical pharmacist-led pharmaceutical care was associated with changes in cardiovascular risk, medication adherence, and health-related quality of life over six months, compared with standard medical care. It also examined medication regimen complexity and its relationship with quality of life in this patient population. The findings indicated that cardiovascular risk scores and medication adherence changed over the follow-up period in both groups. However, the between-group comparison of changes in cardiovascular risk scores did not demonstrate a statistically significant difference. Medication adherence increased in both groups, but the difference between groups at follow-up was not statistically significant. Quality-of-life scores were higher in the intervention group at baseline and at follow-up; therefore, these between-group differences should be interpreted in light of the baseline imbalance. Medication regimen complexity showed a weak negative correlation with quality-of-life scores, suggesting that greater regimen complexity was associated with lower reported quality of life. This study provides an evaluation of clinical pharmacist involvement in the care of hospitalised patients with CKD and highlights the importance of considering medication management, treatment adherence, cardiovascular risk, and quality of life together. The findings should be interpreted in the context of the study design, the final analysed sample, and the differences observed between groups at baseline. Further studies with larger samples and appropriate study designs are needed to clarify the effects of pharmacist-led pharmaceutical care on cardiovascular risk and patient-reported outcomes in people with CKD.
- Company
- Marmara University
- Keywords
- Chronic Kidney Disease (CKD), Cardiovascular (CV) Risk, Quality of Lifte, Medication Adherence, Chronic kidney disease, Clinical pharmacist, Pharmaceutical care, Cardiovascular risk assessment, Medication adherence, Health-related quality of life, Medication regimen complexity, Patient education