StrokeQUATRONCT05741593
Qualitative Analysis of Interviews Between Pharmacist and Elderly Patients Treated with Antithrombotics for an Ischemic Stroke.
An observational study of Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. There are brakes and levers of medication adherence in the context of secondary prevention treatment in stroke. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- Analysis of the verbatim from the transcription of the recorded interviews.
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 and over, hospitalized for an ischemic stroke or a recurrence of ischemic stroke, being already treated with an antithrombotic treatment hospitalized at the Charpennes hospital with a plan to return home
Who may be able to join
- Patients aged 65 and over
- Patients hospitalized for an ischemic stroke or a recurrence of ischemic stroke, already being treated with an antithrombotic treatment (antiplatelet agent or anticoagulant ) prior to the stroke
- Patients living at home and with a plan to return home.
- Patients who did not object to the study and who gave their consent for the recording of the interview
Who cannot join
- Patients with cognitive disorders or stroke sequelae that do not allow a semi-directive interview to be carried out (at medical discretion).
- Non-French speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
institute of aging - Hôpital des Charpennes
Villeurbanne, 69100
Teddy NOVAIS, PharmD, PhD
About this study
Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. There are brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.
Read the detailed description
Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. The probability of stroke recurrence is high: about 25% the first year , and 30 to 40% in the 5 years following the stroke. Recurrent strokes are responsible for significant disability, institutionalization, major neurocognitive disorders, and death.
In order to reduce the risk of stroke recurrence, multiple secondary prevention strategies have demonstrated their effectiveness, such as the prescription of drugs (in particular statins and antithrombotics), the establishment of a balanced diet, the practice of an activity physical, or even tobacco addiction.
However, the effectiveness of these strategies is optimal if and only if patients adhere to them.
In addition, previous studies have focused on the brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.
In elderly patients, other obstacles could have been identified by specific studies, such as cognitive, sensory, functional disorders or even isolation.
- Conditions
- Stroke
- Being tested
- Analysis of the verbatim from the transcription of the recorded interviews.
- Keywords
- Qualitative study, semi-structured interview, antithrombotic, stroke, medication adherence
- Medical subject headings
- Stroke, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the verbatim from the transcription of the recorded interviews.Other
recorded semi-structured interviews between the patients and the pharmacist
| Study group | Role | What they receive |
|---|---|---|
| Patients having had a stroke | elderly patients previously treated with an antithrombotic and admitted to hospital for an ischemic stroke Receives: Other: Analysis of the verbatim from the transcription of the recorded interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the verbatim from the transcription of the recorded interviews.
Describing the content of discussions, relating to antithrombotic treatment for secondary prevention, between elderly patients previously treated with antithrombotics and admitted to hospital for an ischemic stroke and a pharmacist
Measured: one year
Secondary outcomes (4)
Analysis of verbatim statements from the transcription of recorded interviews on patients' representations and beliefs regarding antithrombotics
Exploring patients' representations and beliefs regarding antithrombotics before and after the onset of stroke or recurrence of stroke
Measured: 15 to 60 minutes per patient
Analysis of verbatim statements from the transcription of recorded interviews on patients' medication adherence to antithrombotics
Explore patients' medication adherence to antithrombotics before the onset of stroke or recurrence of stroke
Measured: 15 to 60 minutes per patient
Analysis of verbatim statements from the transcription of recorded interviews on the impact of the occurrence of stroke or recurrence of stroke on medication adherence
Explore the impact of stroke occurrence or stroke recurrence on patient medication adherence (including motivation, ambivalence, confidence in medication benefits)
Measured: 15 to 60 minutes per patient
Analysis of verbatim statements from the transcription of recorded interviews on the obstacles and levers to medication adherence
Identify the barriers and levers to drug adherence with antithrombotics
Measured: 15 to 60 minutes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741593
- Sponsor's protocol ID
- 69HCL22_1074
- Other IDs
- 2023-A00181-44
- Acronym
- QUATRO
- Status last verified
- Nov 2024
- First submitted
- 14 Feb 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Analysis of Interviews Between Pharmacist and Elderly Patients Treated with Antithrombotics for an Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT05741593
- Acronym / sponsor ID
- QUATRO / 69HCL22_1074
- Conditions
- Stroke
- Keywords
- Qualitative study, semi-structured interview, antithrombotic, stroke, medication adherence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 23 Feb 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.
Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. There are brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.
Detailed description
Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. The probability of stroke recurrence is high: about 25% the first year , and 30 to 40% in the 5 years following the stroke. Recurrent strokes are responsible for significant disability, institutionalization, major neurocognitive disorders, and death.
In order to reduce the risk of stroke recurrence, multiple secondary prevention strategies have demonstrated their effectiveness, such as the prescription of drugs (in particular statins and antithrombotics), the establishment of a balanced diet, the practice of an activity physical, or even tobacco addiction.
However, the effectiveness of these strategies is optimal if and only if patients adhere to them.
In addition, previous studies have focused on the brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.
In elderly patients, other obstacles could have been identified by specific studies, such as cognitive, sensory, functional disorders or even isolation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having had a stroke | – | Other: Analysis of the verbatim from the transcription of the recorded interviews.elderly patients previously treated with an antithrombotic and admitted to hospital for an ischemic stroke |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 and over, hospitalized for an ischemic stroke or a recurrence of ischemic stroke, being already treated with an antithrombotic treatment hospitalized at the Charpennes hospital with a plan to return home
Key inclusion criteria (4 listed)
- Patients aged 65 and over
- Patients hospitalized for an ischemic stroke or a recurrence of ischemic stroke, already being treated with an antithrombotic treatment (antiplatelet agent or anticoagulant ) prior to the stroke
- Patients living at home and with a plan to return home.
- Patients who did not object to the study and who gave their consent for the recording of the interview
Key exclusion criteria (2 listed)
- Patients with cognitive disorders or stroke sequelae that do not allow a semi-directive interview to be carried out (at medical discretion).
- Non-French speaking patients
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 |
|---|---|---|
| Analysis of the verbatim from the transcription of the recorded interviews.recorded semi-structured interviews between the patients and the pharmacist | Other | Patients having had a stroke |
Primary outcome
Analysis of the verbatim from the transcription of the recorded interviews.
Time frame: one year
Describing the content of discussions, relating to antithrombotic treatment for secondary prevention, between elderly patients previously treated with antithrombotics and admitted to hospital for an ischemic stroke and a pharmacist
4 secondary outcomes
Analysis of verbatim statements from the transcription of recorded interviews on patients' representations and beliefs regarding antithrombotics
Time frame: 15 to 60 minutes per patient
Analysis of verbatim statements from the transcription of recorded interviews on patients' medication adherence to antithrombotics
Time frame: 15 to 60 minutes per patient
Analysis of verbatim statements from the transcription of recorded interviews on the impact of the occurrence of stroke or recurrence of stroke on medication adherence
Time frame: 15 to 60 minutes per patient
Analysis of verbatim statements from the transcription of recorded interviews on the obstacles and levers to medication adherence
Time frame: 15 to 60 minutes per patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teddy Novais, PharmD, PhD (+33472432155, teddy.novais@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the verbatim from the transcription of the recorded interviews. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.