Mobile Technologies and Post-stroke Depression

Stroke Clinical Trial

— MOTIV-POSDEP  

Official title:

MObile Technologies In the preVention of POSt-stroke DEPression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04043052
• Other study ID #: CHUBX 2017/49
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: September 9, 2023

Study information

• Verified date: June 2021
• Source: University Hospital, Bordeaux
• Contact: Igor SIBON
• Phone: 05 56 79 55 20
• Email: igor.sibon[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: September 9, 2023
• Est. primary completion date: September 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Stroke

Intervention

Other:
• Psychological evaluation
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;
• Functional evaluation
Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)

Biological:
• Biological assessment
Biological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases.

Other:
• Ecological Momentary Assessment
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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHRU de Brest	Brest
France	CHU Dijon Bourgogne	Dijon
France	CHU de Montpellier	Montpellier
France	Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	3 months
Primary	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.	6 months
Secondary	Mini International Neuropsychiatric Interview (MINI)		Day 0
Secondary	Mini International Neuropsychiatric Interview (MINI)		3 months
Secondary	Mini International Neuropsychiatric Interview (MINI)		6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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).	3 months
Secondary	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).	6 months
Secondary	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).	3 months
Secondary	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).	6 months
Secondary	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").	3 months
Secondary	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").	6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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).	3 months
Secondary	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).	6 months
Secondary	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.	Day 0
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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	Day 0
Secondary	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	3 months
Secondary	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	6 months
Secondary	Recurrent stroke	Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria	3 months
Secondary	Recurrent stroke	Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria	6 months
Secondary	Cardiovascular events post-stroke	Cardiovascular events post-stroke defined by standard clinical criteria	3 months
Secondary	Cardiovascular events post-stroke	Cardiovascular events post-stroke defined by standard clinical criteria	6 months
Secondary	Intensity of post-stroke pain	Intensity of post-stroke pain using a visual analog scale	Day 0
Secondary	Intensity of post-stroke pain	Intensity of post-stroke pain using a visual analog scale	3 months
Secondary	Intensity of post-stroke pain	Intensity of post-stroke pain using a visual analog scale	6 months
Secondary	Pittsburgh Sleep Quality Index	Quality of sleep using the item 6 of the Pittsburgh Sleep Quality Index	Visit 1 ; 3 months ; 6 months
Secondary	Blood pressure	Blood pressure	Visit 1 ; 3 months ; 6 months
Secondary	HbA1c measure	Glycaemic control using the HbA1c measure	3 months ; 6 months
Secondary	LDLc plasmatic measure	Lipidic control using the LDLc plasmatic measure	3 months ; 6 months
Secondary	CRPus plasmatic measure	Systemic inflammation will be evaluated using CRPus plasmatic measure	3 months ; 6 months
Secondary	Smoking Index (HSI)	Tobacco use will be evaluated using the Heaviness of Smoking Index (HSI)	3 months ; 6 months