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

Stroke Clinical Trial

— OBSTACLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153020
• Other study ID #: 69HCL17_0037
• Status: Completed
• Start date: September 11, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche	Lyon

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	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
Primary	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