Qualitative Analysis of Interviews Between Pharmacist and Elderly Patients Treated with Antithrombotics for an Ischemic Stroke. (QUATRO)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Analysis of the verbatim from the transcription of the recorded interviews.

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Teddy Novais, PharmD, PhD; Phone Number: +33472432155; Email: teddy.novais@chu-lyon.fr

Study Locations

• France
  • Villeurbanne, France, 69100
    • Recruiting
    • institute of aging - Hôpital des Charpennes
    • Contact: Teddy NOVAIS, PharmD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients having had a stroke; elderly patients previously treated with an antithrombotic and admitted to hospital for an ischemic stroke	Other: Analysis of the verbatim from the transcription of the recorded interviews.; recorded semi-structured interviews between the patients and the pharmacist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: stroke; medication adherence; Qualitative study; antithrombotic; semi-structured interview
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: 69HCL22_1074; 2023-A00181-44 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No