NCT06129318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

October 19, 2023

Last Update Submit

November 8, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • Measuring Quality of Life

    3, 6 and 12 months

  • The National Institutes of Health Stroke Scale

    24 hours before discharge, 3, 6, 9 and 12 months

  • Stroke Recurrence

    1 year

  • Drug Related Problem

    1 year

Study Arms (2)

Clinical Pharmacist Led Pharmaceutical Care

EXPERIMENTAL

In addition to usual care services, the intervention group was provided with pharmaceutical care by a clinical pharmacist.

Behavioral: Clinical Pharmacist Led Pharmaceutical Care

Control Group

NO INTERVENTION

Usual Care

Interventions

Clinical Pharmacist Led Pharmaceutical CareBEHAVIORAL

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.

Clinical Pharmacist Led Pharmaceutical Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Cengiz KN, Midi I, Sancar M. The effect of clinical pharmacist-led pharmaceutical care services on medication adherence, clinical outcomes and quality of life in patients with stroke: a randomised controlled trial. Int J Clin Pharm. 2025 Feb;47(1):99-106. doi: 10.1007/s11096-024-01811-0. Epub 2024 Oct 12.

    PMID: 39395139DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 19, 2023

First Posted

November 13, 2023

Study Start

March 10, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)