:Effects of Pharmaceutical Care in Stroke Patients

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT06129318
Collaborator
(none)
260
1
2
25.7
10.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Clinical Pharmacist Led Pharmaceutical Care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Investigation of the Effects of Pharmaceutical Care Provided by a Clinical Pharmacist on Stroke Patients
Actual Study Start Date :
Mar 10, 2021
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Control Group

Usual Care

Outcome Measures

Primary Outcome Measures

  1. Blood pressure [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.

  2. Medication Adherence [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. HbA1c [1, 3, 6, 9 and 12 months]

    HbA1c (glycated hemoglobin) value was collected from medical records and recorded as a percentage.

  4. LDL cholesterol [1, 3, 6, 9 and 12 months]

    Low density lipoprotein-cholesterol level was collected from medical records and recorded as mg/dL

  5. Triglyceride [1, 3, 6, 9 and 12 months]

    Triglyceride level was collected from medical records and recorded as mg/dL.

  6. Body mass index [1, 3, 6, 9 and 12 months]

    Body mass index (BMI) was collected from medical records and recorded as kg/m2

Secondary Outcome Measures

  1. Measuring Quality of Life [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.

  2. The National Institutes of Health Stroke Scale [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.

  3. Stroke Recurrence [1 year]

    Stroke recurrence (radiologically and clinically confirmed) within 1 year

  4. Drug Related Problem [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Pendik Research and Training Hospital Istanbul Turkey

Sponsors and Collaborators

  • Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mesut Sancar, Prof. Dr., Marmara University
ClinicalTrials.gov Identifier:
NCT06129318
Other Study ID Numbers:
  • MUHSI-2020/08-34
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023