Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône (OBSTACLE)

The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. One of the major issues for these ever-increasing survivors is the prevention of recurrence. According to data from the 3 French registries, more than 20% of patients have at least one recurrence. Secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence.

This evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in patients included in the STROKE 69 cohort.

Study Overview

• Status: Completed
• Conditions: Stroke; Transient Ischemic Attack
• Intervention / Treatment: Other: Patients with stroke or transient ischemic attack

• Study Type: Observational
• Enrollment (Actual): 633

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69423
    • Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stroke or transient ischemic attack of the Rhone area

Description

Inclusion Criteria:

• Consecutive patients treated for a stroke suspicion at the acute phase,
• with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
• Managed by the Rhône's emergency medical help service (SAMU), in one of the emergency unit or stroke unit of the Rhône area
• Having given their written consent for the extraction of their healthcare consumption data from the Health Insurance databases

Exclusion Criteria:

• Hemorrhagic stroke,
• Patient institutionalized in the year following the stroke / transient ischemic attack,
• Patient unable to take treatment alone.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort of patients with stroke or transient ischemic attack; The cohort will be constituted of all consecutive patients admitted for a stroke or transient ischemic attack by the Rhône's emergency medical help service (SAMU), or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.	Other: Patients with stroke or transient ischemic attack; Determination of factors associated to the conformity to secondary prevention treatment 1, 2 and 3 years post a stroke or transient ischemic attack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to secondary prevention treatment 1 year post a stroke or transient ischemic attack	The overall medication possession ratio is the average of the medication possession ratio calculated for each therapeutic class (antiplatelet agents, anticoagulants, antihypertensives, hypolipidemic agents and oral antidiabetics). The medication possession ratio will be calculated from dispensing data from regional health insurance database and prescription data from the STROKE 69 study. For each patient, a medication possession ratio (CMA7 index) will be obtained by the ratio of the quantity of medication units dispensed to the quantity of medication units prescribed.	1 year post a stroke or transient ischemic attack
Determination of factors influencing compliance with secondary prevention treatment 1 year post a stroke or transient ischemic attack	A phone call will be made to patients 1 year post a stroke or transient ischemic attack. The following determinants will be studied in the 5 dimensions defined by World Health Organization: Socio-economic: level of education, profession, health insurance; Patient and family-social environment: age, sex, marital status, lifestyle, level of patient support in the management of their treatment, representation of the disease and beliefs about medication; Care pathway: management of stroke / TIA in emergency or neurovascular unit, admission to rehabilitation unit, medical consumption and therapeutics acts in the year following stroke / TIA; Pathology: TIA or ischemic stroke, duration of hospitalization in acute phase and type of hospital, history of stroke or TIA, disability and autonomy, fatigue, anxiety and depression, comorbidities; Treatments: therapeutic class and number of treatments / polymedication.	1 year post a stroke or transient ischemic attack

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: 69HCL17_0037

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