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

Hamdard University

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Behavioral: Pharmacist counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT06071065

MU0823-IS

Details and patient eligibility

About

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?

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Basic

Active Comparator group

Description:

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.

Treatment:

Behavioral: Pharmacist counselling

Advanced

Experimental group

Description:

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.

Treatment:

Behavioral: Pharmacist counselling