Clinical trial NCT04043052: Mobile Technologies and Post-stroke Depression
Official title: MObile Technologies In the preVention of POSt-stroke DEPression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Depression
Keywords: Stroke
e-health
Depression
Anxiety
Prevention
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hamilton Depression Rating Scale score (HDRS)
timeFrame: Day 0
measure: Hamilton Depression Rating Scale score (HDRS)
timeFrame: 3 months
measure: Hamilton Depression Rating Scale score (HDRS)
timeFrame: 6 months
Secondary outcomes:
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: Day 0
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: 3 months
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: 6 months
measure: Mood Disorder Questionnaire (MDQ)
timeFrame: 3 months
measure: Mood Disorder Questionnaire (MDQ)
timeFrame: 6 months
measure: Generalized Anxiety Disorder-7 scale (GAD-7)
timeFrame: 3 months
measure: Generalized Anxiety Disorder-7 scale (GAD-7)
timeFrame: 6 months
measure: Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
timeFrame: 3 months
measure: Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
timeFrame: 6 months
measure: Center of Epidemiological Studies-Depression Scale (CES-D)
timeFrame: 3 months
measure: Center of Epidemiological Studies-Depression Scale (CES-D)
timeFrame: 6 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: 3 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: 6 months
measure: Ruminative Response Scale-short form (RRS-short form)
timeFrame: 3 months
measure: Ruminative Response Scale-short form (RRS-short form)
timeFrame: 6 months
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: 3 months
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: 6 months
measure: EuroQoL 5-Dimensions Questionnaire (EQ-5D)
timeFrame: 3 months
measure: EuroQoL 5-Dimensions Questionnaire (EQ-5D)
timeFrame: 6 months
measure: Long-term Unmet Needs after Stroke (LUNS)
timeFrame: 3 months
measure: Long-term Unmet Needs after Stroke (LUNS)
timeFrame: 6 months
measure: Short version of Sarason's Social Support Questionnaire (6 items SSQ)
timeFrame: 3 months
measure: Short version of Sarason's Social Support Questionnaire (6 items SSQ)
timeFrame: 6 months
measure: International Physical Activity Questionnaire (7 items IPAQ)
timeFrame: Day 0
measure: International Physical Activity Questionnaire (7 items IPAQ)
timeFrame: 3 months
measure: International Physical Activity Questionnaire (7 items IPAQ)
timeFrame: 6 months
measure: Percentage of stroke risk
timeFrame: Day 0
measure: Percentage of stroke risk
timeFrame: 3 months
measure: Percentage of stroke risk
timeFrame: 6 months
measure: Recurrent stroke
timeFrame: 3 months
measure: Recurrent stroke
timeFrame: 6 months
measure: Cardiovascular events post-stroke
timeFrame: 3 months
measure: Cardiovascular events post-stroke
timeFrame: 6 months
measure: Intensity of post-stroke pain
timeFrame: Day 0
measure: Intensity of post-stroke pain
timeFrame: 3 months
measure: Intensity of post-stroke pain
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Visit 1 ; 3 months ; 6 months
measure: Blood pressure
timeFrame: Visit 1 ; 3 months ; 6 months
measure: HbA1c measure
timeFrame: 3 months ; 6 months
measure: LDLc plasmatic measure
timeFrame: 3 months ; 6 months
measure: CRPus plasmatic measure
timeFrame: 3 months ; 6 months
measure: Smoking Index (HSI)
timeFrame: 3 months ; 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHRU de Brest
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph
Study officials:
affiliation: University Hospital, Bordeaux
name: Igor SIBON
role: PRINCIPAL_INVESTIGATOR
References: