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

NCT06071065 | Completed

• 1 other identifier: MU0823-IS
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Disease

Keywords

Clinical Pharmacist Intervention; Medication Adherence; Clinical outcomes; Health related Quality of life

Outcome Measures

Primary Outcomes (2)

• Health related Quality of Life

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

  6 months

• Patients Medication Adherence.

  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 Outcomes (3)

• Serum Creatinine

  6 months

• Blood Pressure

  6 months

• Haemoglobin

  6 months

Study Arms (2)

Basic

ACTIVE COMPARATOR

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

Advanced

EXPERIMENTAL

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

Interventions

Pharmacist counselling BEHAVIORAL

Counselling session with Pharmacist about disease and medication therapy.

Advanced; Basic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Akbar Niazi Teaching Hospital

Islamabad, Islamabad, Pakistan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Medication Adherence

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Matti Ullah, PhD

  Hamdard University Islamabad Campus

  STUDY DIRECTOR

• Iqra Sagheer

  Akbar Niazi Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Muhammad Masoom Akhter, PhD

  Hamdard University Islamabad Campus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were not informed of which groups they belonged to and what type of intervention is provided.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 6, 2023
• Study Start: September 22, 2023
• Primary Completion: March 20, 2024
• Study Completion: May 20, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

PA (1)