:Effects of Pharmaceutical Care in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06129318
• Other study ID #: MUHSI-2020/08-34
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	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
Primary	Medication Adherence	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
Primary	HbA1c	HbA1c (glycated hemoglobin) value was collected from medical records and recorded as a percentage.	1, 3, 6, 9 and 12 months
Primary	LDL cholesterol	Low density lipoprotein-cholesterol level was collected from medical records and recorded as mg/dL	1, 3, 6, 9 and 12 months
Primary	Triglyceride	Triglyceride level was collected from medical records and recorded as mg/dL.	1, 3, 6, 9 and 12 months
Primary	Body mass index	Body mass index (BMI) was collected from medical records and recorded as kg/m2	1, 3, 6, 9 and 12 months
Secondary	Measuring Quality of Life	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
Secondary	The National Institutes of Health Stroke Scale	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
Secondary	Stroke Recurrence	Stroke recurrence (radiologically and clinically confirmed) within 1 year	1 year
Secondary	Drug Related Problem	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