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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06071065
• Other study ID #: MU0823-IS
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: October 2023
• Source: Hamdard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: April 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Pharmacist counselling
Counselling session with Pharmacist about disease and medication therapy.

Locations

Country	Name	City	State
Pakistan	Akbar Niazi Teaching Hospital	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Hamdard University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related Quality of Life	Patients health related quality of life will be assessed using pre-validated tool RAND-36	6 months
Primary	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	Serum Creatinine	Change in serum creatinine levels after intervention	6 months
Secondary	Blood Pressure	Change in Mean arterial Blood pressure	6 months
Secondary	Haemoglobin	Change in blood haemoglobin levels following intervention	6 months