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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05741593
Other study ID # 69HCL22_1074
Secondary ID 2023-A00181-44
Status Recruiting
Phase
First received
Last updated
Start date April 7, 2023
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source Hospices Civils de Lyon
Contact Teddy Novais, PharmD, PhD
Phone +33472432155
Email teddy.novais@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Analysis of the verbatim from the transcription of the recorded interviews.
recorded semi-structured interviews between the patients and the pharmacist

Locations

Country Name City State
France institute of aging - Hôpital des Charpennes Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one year
Secondary 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 15 to 60 minutes per patient
Secondary 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 15 to 60 minutes per patient
Secondary 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) 15 to 60 minutes per patient
Secondary 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 15 to 60 minutes per patient
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