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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03153020
Collaborator
(none)
633
1
27.6
22.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients with stroke or transient ischemic attack

Study Design

Study Type:
Observational
Actual Enrollment :
633 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône
Actual Study Start Date :
Sep 11, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Compliance to secondary prevention treatment 1 year post a stroke or transient ischemic attack [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.

  2. Determination of factors influencing compliance with secondary prevention treatment 1 year post a stroke or transient ischemic attack [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche Lyon France 69423

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03153020
Other Study ID Numbers:
  • 69HCL17_0037
First Posted:
May 15, 2017
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2021