: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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings