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

NCT ID: NCT06071065

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2024-05-20

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.

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pharmacist counselling

Intervention Type: BEHAVIORAL

Counselling session with Pharmacist about disease and medication therapy.

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.

Group Type: EXPERIMENTAL

Pharmacist counselling

Intervention Type: BEHAVIORAL

Counselling session with Pharmacist about disease and medication therapy.

Interventions

Pharmacist counselling

Counselling session with Pharmacist about disease and medication therapy.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamdard University

OTHER

Sponsor Role: lead

Responsible Party

Matti Ullah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matti Ullah, PhD

Role: STUDY_DIRECTOR

Hamdard University Islamabad Campus

Iqra Sagheer

Role: PRINCIPAL_INVESTIGATOR

Akbar Niazi Teaching Hospital

Muhammad Masoom Akhter, PhD

Role: STUDY_CHAIR

Hamdard University Islamabad Campus

Locations

Akbar Niazi Teaching Hospital

Islamabad, Islamabad, Pakistan

Countries

Pakistan

Other Identifiers

MU0823-IS

Identifier Type: -

Identifier Source: org_study_id