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Mobile Technologies and Post-stroke Depression (MOTIV-POSDEP)

Primary Purpose

Stroke, Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychological evaluation
Functional evaluation
Biological assessment
Ecological Momentary Assessment
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, e-health, Depression, Anxiety, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de BordeauxRecruiting
  • CHRU de Brest
  • CHU Dijon Bourgogne
  • CHU de Montpellier
  • Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment As Usual (TAU)

EMA intervention assocuated to Treatment As Usual (EMA-TAU)

Arm Description

Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination

Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination in addition with Ecological Momentary Assessment (EMA) evaluation.

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale score (HDRS)
Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.
Hamilton Depression Rating Scale score (HDRS)
Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.
Hamilton Depression Rating Scale score (HDRS)
Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.

Secondary Outcome Measures

Mini International Neuropsychiatric Interview (MINI)
Mini International Neuropsychiatric Interview (MINI)
Mini International Neuropsychiatric Interview (MINI)
Mood Disorder Questionnaire (MDQ)
13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms.
Mood Disorder Questionnaire (MDQ)
13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms.
Generalized Anxiety Disorder-7 scale (GAD-7)
7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD.
Generalized Anxiety Disorder-7 scale (GAD-7)
7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD.
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD.
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD.
Center of Epidemiological Studies-Depression Scale (CES-D)
20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items).
Center of Epidemiological Studies-Depression Scale (CES-D)
20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items).
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day).
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day).
Ruminative Response Scale-short form (RRS-short form)
Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 ("almost never") to 4 ("almost always").
Ruminative Response Scale-short form (RRS-short form)
Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 ("almost never") to 4 ("almost always").
Multidimensional Fatigue Inventory (MFI)
The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from "Yes, that is true" to "No, that is not true") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue.
Multidimensional Fatigue Inventory (MFI)
The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from "Yes, that is true" to "No, that is not true") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue.
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients.
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients.
Long-term Unmet Needs after Stroke (LUNS)
The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of "double-barrelled" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any.
Long-term Unmet Needs after Stroke (LUNS)
The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of "double-barrelled" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any.
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied).
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied).
International Physical Activity Questionnaire (7 items IPAQ)
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
International Physical Activity Questionnaire (7 items IPAQ)
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
International Physical Activity Questionnaire (7 items IPAQ)
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Percentage of stroke risk
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Percentage of stroke risk
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Percentage of stroke risk
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Recurrent stroke
Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria
Recurrent stroke
Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria
Cardiovascular events post-stroke
Cardiovascular events post-stroke defined by standard clinical criteria
Cardiovascular events post-stroke
Cardiovascular events post-stroke defined by standard clinical criteria
Intensity of post-stroke pain
Intensity of post-stroke pain using a visual analog scale
Intensity of post-stroke pain
Intensity of post-stroke pain using a visual analog scale
Intensity of post-stroke pain
Intensity of post-stroke pain using a visual analog scale
Pittsburgh Sleep Quality Index
Quality of sleep using the item 6 of the Pittsburgh Sleep Quality Index
Blood pressure
Blood pressure
HbA1c measure
Glycaemic control using the HbA1c measure
LDLc plasmatic measure
Lipidic control using the LDLc plasmatic measure
CRPus plasmatic measure
Systemic inflammation will be evaluated using CRPus plasmatic measure
Smoking Index (HSI)
Tobacco use will be evaluated using the Heaviness of Smoking Index (HSI)

Full Information

First Posted
July 25, 2019
Last Updated
June 11, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04043052
Brief Title
Mobile Technologies and Post-stroke Depression
Acronym
MOTIV-POSDEP
Official Title
MObile Technologies In the preVention of POSt-stroke DEPression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
September 9, 2023 (Anticipated)
Study Completion Date
September 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression
Keywords
Stroke, e-health, Depression, Anxiety, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm Description
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination
Arm Title
EMA intervention assocuated to Treatment As Usual (EMA-TAU)
Arm Type
Experimental
Arm Description
Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination in addition with Ecological Momentary Assessment (EMA) evaluation.
Intervention Type
Other
Intervention Name(s)
Psychological evaluation
Intervention Description
Psychological evaluation including: MINI (current diagnosis) ; HDRS ; MDQ ; GAD-7 ; PC-PTSD-5 ; Quality of Sleep (item 6 of the Pittsburgh Sleep Quality Index) ; CES-D ; BAI ; RRS-short form ; IES-R ; mYFAS2.0;
Intervention Type
Other
Intervention Name(s)
Functional evaluation
Intervention Description
Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)
Intervention Type
Biological
Intervention Name(s)
Biological assessment
Intervention Description
Biological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases.
Intervention Type
Other
Intervention Name(s)
Ecological Momentary Assessment
Intervention Description
During 3 months after inclusion, a 3 to 5 minutes daily interview will administer questions concerning mood symptoms, activities, stress experience, substance use, social relationships and medication intake, activities, social interaction, environmental conditions, experience of depressed mood, anhedonia, changes in weight, appetite, sleep, fatigue, feelings of worthlessness or inappropriate guilt, concentration or decision-making difficulty
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale score (HDRS)
Description
Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.
Time Frame
Day 0
Title
Hamilton Depression Rating Scale score (HDRS)
Description
Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.
Time Frame
3 months
Title
Hamilton Depression Rating Scale score (HDRS)
Description
Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mini International Neuropsychiatric Interview (MINI)
Time Frame
Day 0
Title
Mini International Neuropsychiatric Interview (MINI)
Time Frame
3 months
Title
Mini International Neuropsychiatric Interview (MINI)
Time Frame
6 months
Title
Mood Disorder Questionnaire (MDQ)
Description
13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms.
Time Frame
3 months
Title
Mood Disorder Questionnaire (MDQ)
Description
13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms.
Time Frame
6 months
Title
Generalized Anxiety Disorder-7 scale (GAD-7)
Description
7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD.
Time Frame
3 months
Title
Generalized Anxiety Disorder-7 scale (GAD-7)
Description
7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD.
Time Frame
6 months
Title
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
Description
5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD.
Time Frame
3 months
Title
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
Description
5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD.
Time Frame
6 months
Title
Center of Epidemiological Studies-Depression Scale (CES-D)
Description
20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items).
Time Frame
3 months
Title
Center of Epidemiological Studies-Depression Scale (CES-D)
Description
20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items).
Time Frame
6 months
Title
Beck Anxiety Inventory (BAI)
Description
The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day).
Time Frame
3 months
Title
Beck Anxiety Inventory (BAI)
Description
The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day).
Time Frame
6 months
Title
Ruminative Response Scale-short form (RRS-short form)
Description
Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 ("almost never") to 4 ("almost always").
Time Frame
3 months
Title
Ruminative Response Scale-short form (RRS-short form)
Description
Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 ("almost never") to 4 ("almost always").
Time Frame
6 months
Title
Multidimensional Fatigue Inventory (MFI)
Description
The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from "Yes, that is true" to "No, that is not true") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue.
Time Frame
3 months
Title
Multidimensional Fatigue Inventory (MFI)
Description
The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from "Yes, that is true" to "No, that is not true") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue.
Time Frame
6 months
Title
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
Description
The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients.
Time Frame
3 months
Title
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
Description
The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients.
Time Frame
6 months
Title
Long-term Unmet Needs after Stroke (LUNS)
Description
The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of "double-barrelled" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any.
Time Frame
3 months
Title
Long-term Unmet Needs after Stroke (LUNS)
Description
The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of "double-barrelled" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any.
Time Frame
6 months
Title
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Description
Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied).
Time Frame
3 months
Title
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Description
Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied).
Time Frame
6 months
Title
International Physical Activity Questionnaire (7 items IPAQ)
Description
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Time Frame
Day 0
Title
International Physical Activity Questionnaire (7 items IPAQ)
Description
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Time Frame
3 months
Title
International Physical Activity Questionnaire (7 items IPAQ)
Description
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Time Frame
6 months
Title
Percentage of stroke risk
Description
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Time Frame
Day 0
Title
Percentage of stroke risk
Description
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Time Frame
3 months
Title
Percentage of stroke risk
Description
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Time Frame
6 months
Title
Recurrent stroke
Description
Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria
Time Frame
3 months
Title
Recurrent stroke
Description
Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria
Time Frame
6 months
Title
Cardiovascular events post-stroke
Description
Cardiovascular events post-stroke defined by standard clinical criteria
Time Frame
3 months
Title
Cardiovascular events post-stroke
Description
Cardiovascular events post-stroke defined by standard clinical criteria
Time Frame
6 months
Title
Intensity of post-stroke pain
Description
Intensity of post-stroke pain using a visual analog scale
Time Frame
Day 0
Title
Intensity of post-stroke pain
Description
Intensity of post-stroke pain using a visual analog scale
Time Frame
3 months
Title
Intensity of post-stroke pain
Description
Intensity of post-stroke pain using a visual analog scale
Time Frame
6 months
Title
Pittsburgh Sleep Quality Index
Description
Quality of sleep using the item 6 of the Pittsburgh Sleep Quality Index
Time Frame
Visit 1 ; 3 months ; 6 months
Title
Blood pressure
Description
Blood pressure
Time Frame
Visit 1 ; 3 months ; 6 months
Title
HbA1c measure
Description
Glycaemic control using the HbA1c measure
Time Frame
3 months ; 6 months
Title
LDLc plasmatic measure
Description
Lipidic control using the LDLc plasmatic measure
Time Frame
3 months ; 6 months
Title
CRPus plasmatic measure
Description
Systemic inflammation will be evaluated using CRPus plasmatic measure
Time Frame
3 months ; 6 months
Title
Smoking Index (HSI)
Description
Tobacco use will be evaluated using the Heaviness of Smoking Index (HSI)
Time Frame
3 months ; 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor SIBON
Phone
05 56 79 55 20
Email
igor.sibon@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor SIBON
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor SIBON
Phone
05 56 79 55 20
Email
igor.sibon@chu-bordeaux.fr
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29 609
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge TIMSIT
Phone
02 98 34 76 20
Email
serge.timsit@chu-brest.fr
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21 079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick BEJOT
Phone
03.80.29.37.53
Email
yannick.bejot@chu-dijon.fr
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline ARQUIZAN
Email
c-arquizan@chu-montpellier.fr
Facility Name
Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph
City
Paris
ZIP/Postal Code
75 014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu ZUBER

12. IPD Sharing Statement

Plan to Share IPD
No

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Mobile Technologies and Post-stroke Depression

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