Clinical trial NCT06071065: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Clinical Pharmacist Intervention
Medication Adherence
Clinical outcomes
Health related Quality of life
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Health related Quality of Life
timeFrame: 6 months
measure: Patients Medication Adherence.
timeFrame: 6 months
Secondary outcomes:
measure: Serum Creatinine
timeFrame: 6 months
measure: Blood Pressure
timeFrame: 6 months
measure: Haemoglobin
timeFrame: 6 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Akbar Niazi Teaching Hospital
Study officials:
affiliation: Hamdard University Islamabad Campus
name: Matti Ullah, PhD
role: STUDY_DIRECTOR
affiliation: Akbar Niazi Teaching Hospital
name: Iqra Sagheer
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamdard University Islamabad Campus
name: Muhammad Masoom Akhter, PhD
role: STUDY_CHAIR
References: