StrokeNCT06129318
:Effects of Pharmaceutical Care in Stroke Patients
A study testing Clinical Pharmacist Led Pharmaceutical Care in people with Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Clinical Pharmacist Led Pharmaceutical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being diagnosed with stroke,
- being 18 years old or older,
- being in the cognition to receive the training to be given
Who cannot join
- Not having adequate cognitive function such as dementia,
- being pregnant, lactating,
- having cancer.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Research and Training Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Clinical Pharmacist Led Pharmaceutical Care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist Led Pharmaceutical CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pharmacist Led Pharmaceutical Care | Experimental | In addition to usual care services, the intervention group was provided with pharmaceutical care by a clinical pharmacist. Receives: Behavioral: Clinical Pharmacist Led Pharmaceutical Care |
| Control Group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3, 6, 9 and 12 months
HbA1c
HbA1c (glycated hemoglobin) value was collected from medical records and recorded as a percentage.
Measured: 1, 3, 6, 9 and 12 months
LDL cholesterol
Low density lipoprotein-cholesterol level was collected from medical records and recorded as mg/dL
Measured: 1, 3, 6, 9 and 12 months
Triglyceride
Triglyceride level was collected from medical records and recorded as mg/dL.
Measured: 1, 3, 6, 9 and 12 months
Body mass index
Body mass index (BMI) was collected from medical records and recorded as kg/m2
Measured: 1, 3, 6, 9 and 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 24 hours before discharge, 3, 6, 9 and 12 months
Stroke Recurrence
Stroke recurrence (radiologically and clinically confirmed) within 1 year
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start10 Mar 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Sancar, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129318
- Sponsor's protocol ID
- MUHSI-2020/08-34
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39395139
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pharmaceutical Care Provided by a Clinical Pharmacist on Stroke Patients
- ClinicalTrials.gov ID
- NCT06129318
- Acronym / sponsor ID
- MUHSI-2020/08-34
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Pharmacist Led Pharmaceutical Care | Experimental | Behavioral: Clinical Pharmacist Led Pharmaceutical CareIn addition to usual care services, the intervention group was provided with pharmaceutical care by a clinical pharmacist. |
| Control Group | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being diagnosed with stroke,
- being 18 years old or older,
- being in the cognition to receive the training to be given
Key exclusion criteria (3 listed)
- Not having adequate cognitive function such as dementia,
- being pregnant, lactating,
- having cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Pharmacist Led Pharmaceutical CareWithin 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. | Behavioural | Clinical Pharmacist Led Pharmaceutical Care |
Primary outcome
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.
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.
HbA1c
Time frame: 1, 3, 6, 9 and 12 months
HbA1c (glycated hemoglobin) value was collected from medical records and recorded as a percentage.
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
Triglyceride
Time frame: 1, 3, 6, 9 and 12 months
Triglyceride level was collected from medical records and recorded as mg/dL.
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
4 secondary outcomes
Measuring Quality of Life
Time frame: 3, 6 and 12 months
The National Institutes of Health Stroke Scale
Time frame: 24 hours before discharge, 3, 6, 9 and 12 months
Stroke Recurrence
Time frame: 1 year
Drug Related Problem
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 39395139Cengiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist Led Pharmaceutical Care in people with Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 1, 3, 6, 9 and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06129318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.