:Effects of Pharmaceutical Care in Stroke Patients

November 8, 2023 updated by: Mesut Sancar, Marmara University

Investigation of the Effects of Pharmaceutical Care Provided by a Clinical Pharmacist on Stroke Patients

To evaluate the effects of the 1-year pharmaceutical care program offered by the clinical pharmacist to the patients admitted to the neurology service with the diagnosis of stroke, on medication adherence, quality of life, and clinical outcomes of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted as a parallel randomized controlled study in the Neurology Clinic of a University Hospital in Turkey. Patients were randomly assigned to intervention and usual care groups. While the patients in the usual care group are given routine health services by the neurologist during their hospitalization and for 1 year after discharge; In addition to these routine services, the intervention group was provided with pharmaceutical care by a clinical pharmacist during the same period. The study was always conducted by the same neurologist and clinical pharmacist. Patient medication adherence, quality of life, and clinical parameters were evaluated at the beginning of the study and at the 12th month.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University Pendik Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • being diagnosed with stroke,
  • being 18 years old or older,
  • being in the cognition to receive the training to be given

Exclusion Criteria:

  • Not having adequate cognitive function such as dementia,
  • being pregnant, lactating,
  • having cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Usual Care
Experimental: Clinical Pharmacist Led Pharmaceutical Care
In addition to usual care services, the intervention group was provided with pharmaceutical care by a clinical pharmacist.
Behavioral: Clinical Pharmacist Led Pharmaceutical Care
Within the scope of pharmaceutical care, medication review services for past and current medication use were provided by the clinical pharmacist. The patients in the intervention group were given verbal information about the definition of stroke, symptoms, how to manage risk factors, and their medications by the clinical pharmacist on the day of discharge, in addition to the neurologist. Each patient in the intervention group had a scheduled meeting with the clinical pharmacist. During the 1-year follow-up the patient education given by the clinical pharmacist was repeated every 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 1, 3, 6, 9 and 12 months
Blood pressure was checked and recorded by a qualified nurse during the hospital stay and at control visits. Measurements were recorded as mmHg.
1, 3, 6, 9 and 12 months
Medication Adherence
Time Frame: 3, 6, 9 and 12 months
Adherence to Stroke Prevention Medications (Anti platelets, Anticoagulants, Statins, antihypertensives, antidiabetics) measured by Morisky-Green-Levine Adherence Scale (1-4) where higher scores indicate higher levels of reported adherence.
3, 6, 9 and 12 months
HbA1c
Time Frame: 1, 3, 6, 9 and 12 months
HbA1c (glycated hemoglobin) value was collected from medical records and recorded as a percentage.
1, 3, 6, 9 and 12 months
LDL cholesterol
Time Frame: 1, 3, 6, 9 and 12 months
Low density lipoprotein-cholesterol level was collected from medical records and recorded as mg/dL
1, 3, 6, 9 and 12 months
Triglyceride
Time Frame: 1, 3, 6, 9 and 12 months
Triglyceride level was collected from medical records and recorded as mg/dL.
1, 3, 6, 9 and 12 months
Body mass index
Time Frame: 1, 3, 6, 9 and 12 months
Body mass index (BMI) was collected from medical records and recorded as kg/m2
1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring Quality of Life
Time Frame: 3, 6 and 12 months
The patients' quality of life was evaluated using the Stroke-Specific Quality of Life Scale (SSQOL), and the total quality of life score was calculated, a higher score indicates that the patient has a better quality of life.
3, 6 and 12 months
The National Institutes of Health Stroke Scale
Time Frame: 24 hours before discharge, 3, 6, 9 and 12 months
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS), is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke and aid in planning post-acute care disposition.
24 hours before discharge, 3, 6, 9 and 12 months
Stroke Recurrence
Time Frame: 1 year
Stroke recurrence (radiologically and clinically confirmed) within 1 year
1 year
Drug Related Problem
Time Frame: 1 year
Determination of drug-related problems (DRP) using Pharmaceutical Care Network Europe (PCNE) Version 9.1. The basic classification has 3 primary domains for problems, 9 primary domains for causes and 5 primary domains for Planned Interventions, 3 primary domains for level of acceptance (of interventions) and 4 primary domains for the Status of the problem.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUHSI-2020/08-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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