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Chronic Kidney DiseaseNCT06071065

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

A study testing Pharmacist counselling in people with Chronic Kidney Disease, run by Hamdard University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Pharmacist counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 sitePakistan
Study dates
22 Sep 2023to 20 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Pakistan1 site

  • Akbar Niazi Teaching Hospital

    Islamabad, Islamabad

Other trials in Pakistan

About this study

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

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?
Read the 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.

Being tested
Pharmacist counselling
Keywords
Clinical Pharmacist Intervention, Medication Adherence, Clinical outcomes, Health related Quality of life
Medical subject headings
Renal Insufficiency, Chronic, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist counsellingBehavioural

    Counselling session with Pharmacist about disease and medication therapy.

Study groups in NCT06071065
Study groupRoleWhat they receive
BasicActive comparatorBasic 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.
Receives: Behavioral: Pharmacist counselling
AdvancedExperimentalIn 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.
Receives: Behavioral: Pharmacist counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health related Quality of Life

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

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (3)

  1. Serum Creatinine

    Change in serum creatinine levels after intervention

    Measured: 6 months

  2. Blood Pressure

    Change in Mean arterial Blood pressure

    Measured: 6 months

  3. Haemoglobin

    Change in blood haemoglobin levels following intervention

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2023
  2. Study start22 Sep 2023
  3. Primary completion20 Mar 2024
  4. Study completion20 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06071065
Sponsor's protocol ID
MU0823-IS
Status last verified
Jan 2025
First submitted
20 Sep 2023
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Depends on the patient Consent

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist counselling in people with Chronic Kidney Disease, run by Hamdard University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related Quality of Life (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06071065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.

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