Informations générales (source: ClinicalTrials.gov)
MObile Technologies In the preVention of POSt-stroke DEPression (MOTIV-POSDEP)
Interventional
N/A
University Hospital, Bordeaux (Voir sur ClinicalTrials)
septembre 2020
septembre 2023
29 juin 2024
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 to the heavy burden of stroke. While these conditions
affect about 25% of stroke patients at 3 months, they are under-reported spontaneously by
patients and are under-evaluated and treated by clinicians. Other than stroke severity
and psychiatric history, risk factors for post-stroke depression remain a matter of
debate, thus preventing identification of high-risk patients. Moreover, to date, neither
pharmacological nor nonpharmacological treatments have demonstrated a significant benefit
in the prevention of this disorder, thereby also impeding the development of early
treatment strategies. Yet,the early management of post-stroke depression is critical
given its negative influence on long-term functional outcomes, medication adherence,
efficient use of rehabilitation services and the risk of stroke recurrence or vascular
events. There is a pressing need to develop new tools allowing for the early detection of
post-stroke neuropsychiatric complications for each individual patient. The rapid
expansion of ambulatory monitoring techniques, such as Ecological Momentary Assessment
(EMA), allows daily evaluations of mood symptoms in real time and in the natural contexts
of daily life. The investigators have previously validated the feasibility and validity
of EMA to assess daily life emotional symptoms after stroke, demonstrating its utility to
investigate their evolution during the 3 months following stroke and to identify early
predictors of post-stroke depression such as stress reactivity and social support,
suggesting that EMA could be used in the early personalized care management of these
neuropsychiatric complications. Recently, preliminary data have also emphasized the
potential of EMA interventions to improve the outcome of psychiatric disorders.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Mathieu ZUBER | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Brest - 29 609 - Brest - France | Serge TIMSIT | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Bordeaux - 33 076 - Bordeaux - France | Igor SIBON | Contact (sur clinicalTrials) | |||
| CHU de Montpellier - 34295 - Montpellier - France | Caroline ARQUIZAN | Contact (sur clinicalTrials) | |||
| CHU Dijon Bourgogne - 21 079 - Dijon - France | Yannick BEJOT | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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