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NCT Number: NCT06071065

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

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?

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Key information

Conditions

Chronic Kidney Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Kidney Diseases Male Urogenital Diseases Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Renal Insufficiency Renal Insufficiency, Chronic Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akbar Niazi Teaching Hospital

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacist counselling

Behavioral

Counselling session with Pharmacist about disease and medication therapy.

Primary outcomes

  1. Health related Quality of Life

    Time frame: 6 months

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

  2. Patients Medication Adherence.

    Time frame: 6 months

    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 outcomes

  1. Serum Creatinine

    Time frame: 6 months

    Change in serum creatinine levels after intervention

  2. Blood Pressure

    Time frame: 6 months

    Change in Mean arterial Blood pressure

  3. Haemoglobin

    Time frame: 6 months

    Change in blood haemoglobin levels following intervention

Sponsors and collaborators

Lead sponsor

Hamdard University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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