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Impact of pharmacist led interventions for drug related problems among chronic kidney disease patients: A randomized control trial

Impact of pharmacist led interventions for drug related problems among chronic kidney disease patients: A randomized control trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000370606
Enrollment
100
Registered
2023-04-13
Start date
2023-04-15
Completion date
2023-10-31
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic kidney disease (CKD) is considered as a major public health concern affecting 10-15% of the world population. Worldwide, hypertension and diabetes are considered the main causes of CKD and these patients need to be prescribed multiple drugs. Hence; increasing the risk of drug related problems. In Pakistan, the healthcare system is already overburdened, Clinical Pharmacist being a member of the healthcare team, is at a better position if involved in monitoring of drug therapies. The main goal of managing CKD is to improve patients’ quality of life (QoL) by delaying progression of CKD related complications, increase patient survival rate and reduce the healthcare cost. The aim of this study is to determine the impact of pharmacist led interventions for avoiding drug related problems and to understand the comparison of renal dose adjustment, drug interactions and pharmacist knowledge in health care setting among CKD patients in Pakistan. The present study is designed as a randomized control trial. In randomized control trial, for intervention group, a proper pharmacist led interventions will be designed and developed to address the drug related problems including drug interactions in order to improve therapeutic outcomes. Drug related problems and Levels of Pharmacy Intervention will be classified, based on the Pharmaceutical Care Network Europe [PCNE] Scale version 9.1. Patient quality of life (QoL) will be assessed by using a Functional Assessment of Non-Life Threatening Conditions [FANLTC] (Version 4) questionnaire. British National Formulary, Drug Facts and Comparison will be used to identify drugs requiring special renal dose adjustments while drug interactions will be assessed by using Lexicomp Up to date Software.

Interventions

In the randomized control trial, patients meeting the inclusion criteria will be randomly assigned to control group and intervention group after taking consent for participation in the study. Data collection form will be designed and developed in order to record patient demographics, medications history, prescribed drugs and laboratory parameters, stages of chronic kidney disease based on Cockgraft Gault Equation. Patient quality of life will be assessed by using a Functional Assessment of Non

In the randomized control trial, patients meeting the inclusion criteria will be randomly assigned to control group and intervention group after taking consent for participation in the study. Data collection form will be designed and developed in order to record patient demographics, medications history, prescribed drugs and laboratory parameters, stages of chronic kidney disease based on Cockgraft Gault Equation. Patient quality of life will be assessed by using a Functional Assessment of Non-Life Threatening Conditions [FANLTC] (Version 4) questionnaire at baseline and also at end of study (12 week). The patients in control group will be having usual medication and usual care as per their routine without any involvement of pharmacist or counseling. The patients in the intervention group will be given a counseling session by the pharmacist regarding disease knowledge, medication reconciliation, need of dose adjustment and drug-interactions in CKD patients, and its impact on disease progression and quality of life (QOL), where needed either during hospital stay or at the time of discharge, anticipated to take up to 15 to 20 minutes . Drug related problems and levels of Pharmacy Intervention will be classified, based on the Pharmaceutical Care Network Europe [PCNE] Scale version 9.1, British National Formulary [BNF] will be used to identify drugs requiring special renal dose adjustments while drug interactions will be assessed by using Lexicomp Up to date Software. At end point (12 weeks) the patient quality of life will be assessed by using Functional Assessment of Non-Life Threatening Condition [FANLTC] questionnaire.

Sponsors

Dr. Inayat Ur Rehman (PhD Clinical Pharmacy)
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants of this RCT must be adult patients of 18 years and above, both genders who currently had or previously diagnosed with all stages of renal disease.

Exclusion criteria

Participants not having renal disease,those who are pregnant and breastfeeding and not willing to participate.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026