Status:
COMPLETED
Mobile Technologies and Post-stroke Depression
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Stroke
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The recent development of acute phase treatments has dramatically improved stroke functional outcome but post-stroke neuropsychiatric disorders, notably post-stroke depression, continue to contribute ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Male or Female.
- Recent (≤ 15 days) clinically-symptomatic ischemic or hemorrhagic stroke documented through brain imaging (CT or MRI) or a Transient Ischemic Attack with an ABCD2 score ≥ 4.
- Patient discharged to home after hospitalization in the stroke unit.
- No severe neurological handicap: modified Rankin scale ≤ 3 at inclusion.
- No severe cognitive impairment or dementia: MoCA ≥ 16 at inclusion.
- Written informed consent by the patient.
- Covered by French Social Insurance
Exclusion
- Transient Non Cerebrovascular Event.
- Subarachnoid hemorrhage.
- Dementia syndrome or other neurologic disorder and/or severe aphasia (NIHSS item 9 ≥ 2) interfering with the completion of evaluations and the utilization of EMA.
- Severe visual impairment interfering with the utilization of EMA.
- Severely impaired physical and/or mental health that, according to the investigator, may affect the participant's compliance with the study
- Patients with a severe substance use disorder (DSM-5 criteria)
- Patients under antidepressant and/or anxiolytic and/or neuroleptic and/or mood stabilizer treatment during the month preceding inclusion
- Participation in another protocol modifying the patient's follow-up status.
- Pregnancy or breastfeeding
- Inability to read French or to use a smartphone
- Individuals under legal protection or unable to express personnally their consent
- Individuals living in an area without 3G/4G internet coverage
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2025
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT04043052
Start Date
September 9 2020
End Date
March 23 2025
Last Update
July 20 2025
Active Locations (5)
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1
CHU de Bordeaux
Bordeaux, France, 33 076
2
CHRU de Brest
Brest, France, 29 609
3
CHU Dijon Bourgogne
Dijon, France, 21 079
4
CHU de Montpellier
Montpellier, France, 34295