Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients

January 29, 2025 updated by: Matti Ullah, Hamdard University

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

For evaluation of clinical outcome Blood pressure, serum creatinine, and hemoglobin will be obtained from medical records (from hospital software or from patient who had done their labs from out sources)during the baseline visit. The same laboratory tests will also be assessed at patients three-time intervals at admission or first visit at the start of treatment, week 8, and week 16.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan
        • Akbar Niazi Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Basic

Basic intervention included the usual counselling by a clinical pharmacist e.g.

  1. Patients Education

    • Pharmacist counseling regarding their disease type and severity
    • Pharmacist counseling (15- to 20-minute sessions) on the proper use of medication
    • Pharmacist counseling regarding the importance of their therapy (treatment)
    • Labeling of medication packs to assist pill sorting. Labels included instructions on dose and frequency/ timing of medication doses

  2. Optimizing therapy monitoring

    • Prescription information quality (incomplete prescription)
    • wrong dose
    • wrong frequency etc.
Behavioral: Pharmacist counselling
Counselling session with Pharmacist about disease and medication therapy.
Experimental: Advanced

In addition to Basic Intervention:

  1. Preventing drug interactions :

    • Detection or assessment of potential DDIs by a pharmacist prior to the start of treatment and recommendations for their management.

  2. Patient Education regarding Medications :

    • Pharmacist counseling (15- to 20-minute sessions) on the proper use of medication.
    • Pharmacist counseling on the safe use of medication (self-medication or over-the-counter [OTC] medicines)

  3. Preventing an adverse drug event

    • Monitoring, and prompt detection of adverse drug events (ADEs)

  4. Education on lifestyle modifications

    • Education on lifestyle e.g. regarding exercise
    • Renal diet plan will be given to patients

  5. Renal Dose Adjustments :

    • Detection or assessment of potential nephrotoxic drugs by a pharmacist prior to start of treatment and recommendations for their renal dose adjustment.
Behavioral: Pharmacist counselling
Counselling session with Pharmacist about disease and medication therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related Quality of Life
Time Frame: 6 months
Patients health related quality of life will be assessed using pre-validated tool RAND-36
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Creatinine
Time Frame: 6 months
Change in serum creatinine levels after intervention
6 months
Blood Pressure
Time Frame: 6 months
Change in Mean arterial Blood pressure
6 months
Haemoglobin
Time Frame: 6 months
Change in blood haemoglobin levels following intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamdard University

Investigators

  • Study Director: Matti Ullah, PhD, Hamdard University Islamabad Campus
  • Principal Investigator: Iqra Sagheer, Akbar Niazi Teaching Hospital
  • Study Chair: Muhammad Masoom Akhter, PhD, Hamdard University Islamabad Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Actual)

March 20, 2024

Study Completion (Actual)

May 20, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU0823-IS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depends on the patient Consent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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