:Effects of Pharmaceutical Care in Stroke Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Clinical Pharmacist Led Pharmaceutical Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Pharmacist Led Pharmaceutical Care<br>In addition to usual care services, the intervention group was provided with pharmaceutical care by a clinical pharmacist. | Behavioral: Clinical Pharmacist Led Pharmaceutical Care<br>* 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.<br>|
| No Intervention: Control Group<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| HbA1c | HbA1c (glycated hemoglobin) value was collected from medical records and recorded as a percentage. | 1, 3, 6, 9 and 12 months | 
| LDL cholesterol | Low density lipoprotein-cholesterol level was collected from medical records and recorded as mg/dL | 1, 3, 6, 9 and 12 months | 
| Triglyceride | Triglyceride level was collected from medical records and recorded as mg/dL. | 1, 3, 6, 9 and 12 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Stroke Recurrence | Stroke recurrence (radiologically and clinically confirmed) within 1 year | 1 year | 
| 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 |