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Clinical Trials/NCT06071065
NCT06071065CompletedNot Applicable

Impact of Clinical Pharmacist Intervention on Medication Adherence and Its Association with Clinical Outcomes in Chronic Kidney Disease in Islamabad

Hamdard University1 site in 1 country130 target enrollmentStarted: September 22, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
130
Locations
1
Primary Endpoint
Patients Medication Adherence.

Study Overview

Brief Summary

The purpose of this research study is to evaluate the impact of clinical pharmacist interventions on treatment outcomes, health-related quality of life (HRQoL),and medication adherence among chronic kidney disease patients.

Pharmacist's intervention aim to answer:

  1. How a clinical pharmacist intervention program impact medication adherence in chronic kidney disease?
  2. To assess how patients' counseling and medication adherence impact patient health-related quality of life?
  3. How a clinical pharmacist intervention program improves clinical outcomes of chronic kidney disease patients?

Detailed Description

This is a randomized, pharmacist-led, two-group, longitudinal descriptive intervention study performed at a private hospital nephrology department. The study included the introduction of clinical pharmacist interventions to improve adherence to prescribed medications, health-related quality of life, and clinical outcomes in patients with Chronic Kidney Disease(CKD).

Recruited patients were randomly divided into two groups; the basic intervention group and the advanced intervention group.

The basic intervention group received routine counseling. An advance intervention group was provided in addition to the usual counseling, education about Chronic Kidney Disease, hypertension or other comorbidity and management, as well as medication adherence, and renal diet (educational infographic for Chronic Kidney Disease patients) at three follow-up intervals after every 2 months. Both groups were followed up for a period of 6 months.

Pre-validated questionnaires will be used for the assessment

  1. Medication Adherence Rating Scale (MARS): to evaluate medication adherence
  2. MOS 36-Item Short Form Survey Instrument (SF-36): For evaluation of health related quality of life.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

Patients were not informed of which groups they belonged to and what type of intervention is provided.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All male and female inpatients and outpatients with chronic kidney disease defined as a creatinine clearance (CrCl) less than 60 ml/min/l, 73 m2
  • over the age of 18 years , will be included in study.
  • Patient who are on maintenance hemodialysis also included.

Exclusion Criteria

  • Patients with acute renal failure
  • Patients who are receiving renal transplants will not be included.
  • Patients who will refuse to participate in study will not be included.

Outcomes

Primary Outcomes

Patients Medication Adherence.

Time Frame: 6 months

The primary aim of this study will be to evaluate the effectiveness/impact of a clinical pharmacist intervention program on medication adherence in chronic kidney disease. Adherence will be measured using Medication Adherence Repoting Scale (MARS-10). This scale describes three-dimension ,medication adherence behaviour (1-4),attitude towards taking medication (5-8),negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response with medication adherence coded as 1 and with non-adherence coded as 0. higher the score higher will be adherence and vice versa.score \<6 showes poor adherence and \> 8 showes good adherehnce.

Health related Quality of Life

Time Frame: 6 months

Patients health related quality of life will be assessed using pre-validated tool RAND-36

Secondary Outcomes

  • Haemoglobin(6 months)
  • Serum Creatinine(6 months)
  • Blood Pressure(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matti Ullah

Assistant Professor

Hamdard University

Study Sites (1)

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