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

Primary Purpose

Chronic Kidney Disease

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pharmacist counselling
Sponsored by
Hamdard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring Clinical Pharmacist Intervention, Medication Adherence, Clinical outcomes, Health related Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Akbar Niazi Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Basic

Advanced

Arm Description

Basic intervention included the usual counselling by a clinical pharmacist e.g. 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 Optimizing therapy monitoring Prescription information quality (incomplete prescription) wrong dose wrong frequency etc.

In addition to Basic Intervention: Preventing drug interactions : • Detection or assessment of potential DDIs by a pharmacist prior to the start of treatment and recommendations for their management. 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) Preventing an adverse drug event • Monitoring, and prompt detection of adverse drug events (ADEs) Education on lifestyle modifications Education on lifestyle e.g. regarding exercise Renal diet plan will be given to patients 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum Creatinine
Change in serum creatinine levels after intervention
Blood Pressure
Change in Mean arterial Blood pressure
Haemoglobin
Change in blood haemoglobin levels following intervention

Full Information

First Posted
September 20, 2023
Last Updated
October 12, 2023
Sponsor
Hamdard University
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1. Study Identification

Unique Protocol Identification Number
NCT06071065
Brief Title
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
Official Title
Impact of Clinical Pharmacist Intervention on Medication Adherence and Its Association With Clinical Outcomes in Chronic Kidney Disease in Islamabad
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamdard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: How a clinical pharmacist intervention program impact medication adherence in chronic kidney disease? To assess how patients' counseling and medication adherence impact patient health-related quality of life? 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 Medication Adherence Rating Scale (MARS): to evaluate medication adherence 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Clinical Pharmacist Intervention, Medication Adherence, Clinical outcomes, Health related Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients were not informed of which groups they belonged to and what type of intervention is provided.
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic
Arm Type
Active Comparator
Arm Description
Basic intervention included the usual counselling by a clinical pharmacist e.g. 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 Optimizing therapy monitoring Prescription information quality (incomplete prescription) wrong dose wrong frequency etc.
Arm Title
Advanced
Arm Type
Experimental
Arm Description
In addition to Basic Intervention: Preventing drug interactions : • Detection or assessment of potential DDIs by a pharmacist prior to the start of treatment and recommendations for their management. 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) Preventing an adverse drug event • Monitoring, and prompt detection of adverse drug events (ADEs) Education on lifestyle modifications Education on lifestyle e.g. regarding exercise Renal diet plan will be given to patients 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.
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist counselling
Intervention Description
Counselling session with Pharmacist about disease and medication therapy.
Primary Outcome Measure Information:
Title
Health related Quality of Life
Description
Patients health related quality of life will be assessed using pre-validated tool RAND-36
Time Frame
6 months
Title
Patients Medication Adherence.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum Creatinine
Description
Change in serum creatinine levels after intervention
Time Frame
6 months
Title
Blood Pressure
Description
Change in Mean arterial Blood pressure
Time Frame
6 months
Title
Haemoglobin
Description
Change in blood haemoglobin levels following intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti Ullah, PhD
Organizational Affiliation
Hamdard University Islamabad Campus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Iqra Sagheer
Organizational Affiliation
Akbar Niazi Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad Masoom Akhter, PhD
Organizational Affiliation
Hamdard University Islamabad Campus
Official's Role
Study Chair
Facility Information:
Facility Name
Akbar Niazi Teaching Hospital
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depends on the patient Consent

Learn more about this trial

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

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