StrokePSDMNCT06837311
Post-Stroke Secondary Prevention With Digital Monitoring
A study testing Ecological Momentary Assessment (EMA), Biological assessment and Psychological examination and Substance Use symptomatology in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Stroke is the second leading cause of death and a major cause of disability worldwide. In 2019, Disability-Adjusted Life-Years (DALYs) related to stroke was estimated to have reached 143 million. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Ecological Momentary Assessment (EMA), Biological assessment and Psychological examination and Substance Use symptomatology
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2025to 25 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- At least 18 years of age and younger than 80 years;
- Recent (≤ 15 days) clinically symptomatic ischemic or hemorrhagic stroke documented through brain imaging (CT or MRI) or a Transient Ischemic Attack with an Predictive Risk Score (ABCD2) ≥ 4;
- Returning to the neurovascular unit for the standard care post-stroke follow-up visits;
- National Institute Health Stroke Scale (NIHSS) < 15;
- modified Rankin scale ≤ 4;
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- No severe cognitive impairment as defined by the neurologist;
- Current smokers (smoking at least 1 cigarette per day during the month before admission)
- Able to use a smartphone
- Living in an area with internet coverage
- Written informed consent by the patient;
- Coverage by the French National Health Insurance
Who cannot join
- Subarachnoid hemorrhage; Dementia syndrome or other central neurologic disorder;
- Severe aphasia (NIHSS item 9 ≥ 2)
- Severe visual impairment interfering with the completion of evaluations;
- Severely impaired physical and/or mental health that, according to the neurologist, may affect the participant's capacity to participate in the study;
- Individuals already undergoing treatment for tobacco cessation and/or SRADs at admission in the stroke unit;
- Pregnancy or breastfeeding;
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- Inability to read French;
- Individuals under legal protection or unable to express personally their consent
- Participation in another protocol modifying the patient's follow-up status.
- Person deprived of liberty
- Person in emergency situation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sylvie BERTHOZ contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Igor SIBON, 05 56 79 55 20, igor.sibon@chu-bordeaux.fr
About this study
Official title: Medical Benefit of Digital Monitoring Using apTeleCare for Secondary Prevention in Patients With a Recent Transient Ischemic Attack or Stroke
Stroke is the second leading cause of death and a major cause of disability worldwide. In 2019, Disability-Adjusted Life-Years (DALYs) related to stroke was estimated to have reached 143 million. Modifiable stroke risk-factors, which include poor lifestyle habits (tobacco, alcohol and illicit drug abuse, dietary patterns at risk, low physical activity), account for 90 % of the risk of stroke. Stroke complications and the risk of stroke recurrence is highly dependent on the control of these risk factors. Thus, the secondary prevention of stroke requires profound lifestyle modifications including substance use cessation and diet changes. National guidelines for stroke clinical practice advocate an immediate cessation of consumption of all substances but without recommendations on specific therapeutic regimens. Moreover, none address the management of poor coping with stress or mood problems though they are major population attributable risk factors of stroke and constitute major barriers of behavior changes achievement. Yet, post-stroke emotional impairments are frequent, post-stroke depression and anxiety being the most frequent (prevalence is 30% and 25%, respectively). Importantly, independently from stroke, emotional impairments or disorders and Substance Related and Addiction Disorders (SRADs) are frequent comorbid conditions (dual disorders) with debilitating consequences and the interplay between the two conditions makes rehabilitation more complex. This suggests that taking into account stroke patients' mental health status might improve not only the management of post-stroke emotional impairments but also the control of stroke vascular risk factors.
Regarding secondary prevention programs focusing on behavioral changes among Cardiovascular and Cerebrovascular Disease (CVD) patients, the literature is sparse and studies on smoking cessation are the most widely documented. Despite the risk of smoking after a myocardial infarct or a stroke/Transient Ischemic Attack (TIA), less than half of patients quit smoking after the event or achieve long-term abstinence.
Read more
To increase treatment adherence and efficacy, besides systematically screening lifestyle habits and evaluating the patients' mental health and motivation to change in clinical routine, experts in the domain emphasize the need to:
- start delivering treatment as early as possible, ideally during hospitalization;
- tailor the intensity of the treatment (combination of pharmacological medications +/- behavioral intervention; frequency of the follow-up/contacts) according to the risk profile of each patient, particularly depending on the level of dependence and the presence of comorbid emotional difficulties/psychiatric disorders.
After hospital discharge, in standard care, the follow-up visit is scheduled 4 to 6 months post-stroke. Knowing that the vast majority of smoking relapses occur in the weeks following stroke, it appears that this period is of high risk for missing the goal of stroke secondary prevention. Therefore, new approaches are urgently needed that would allow for the day-to-day examination of clinical change in the immediate days and weeks following discharge from the stroke acute-care unit to optimize the patient's recovery and quality of life.
The potential pivotal role of eHealth development has been advocated by the World Health Organization, which considers e-Health as a cost-effective and secure use of information and communication technologies (ICT). Used in the context of stroke secondary prevention, eHealth technologies should give each patient the opportunity to describe his/her own experiences and symptoms and the contexts of daily life in which they occur that may constitute negative factors for post-stroke recovery. Post-stroke management would thus be optimized through a person-centered, intense and multidisciplinary care program.
Investigators believe apTeleCare would allow for such a day-to-day examination of clinical change in the immediate days and weeks following discharge from the stroke acute-care unit. It offers the possibility not only to closely monitor patients' experiences and symptoms and the contexts of daily life in which they occur, but also to inform the clinical team in real-time via specific alerts that depend on the type and level of difficulties the patients encounter for adopting the expected changes in their lifestyle
- Conditions
- Stroke
- Being tested
- Ecological Momentary Assessment (EMA), Biological assessment, Psychological examination and Substance Use symptomatology, Treatment as usual (TAU), Expired carbon monoxide (CO)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary Assessment (EMA)Device
Daily ecological momentary assessment (EMA), in addition to treatment as usual (TAU) using apTeleCare eHealth device. Daily surveys includes questions reflecting all Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 symptom criteria for Depression, Generalized Anxiety Disorder, Post-Traumatic Symptom Disorder, evaluations of substance use (including dietary items at risk) as well as of two symptoms predictive of relapse (craving and loss of control), medication compliance and physical activity
Biological assessmentBiological
Routine Biological assessment and of substance use
Psychological examination and Substance Use symptomatologyBehavioural
Substance use symptomatology ; Neuropsychiatric symptomatology ; Functional outcomes ; Neurologic and Cardiovascular outcomes
Treatment as usual (TAU)
Expired carbon monoxide (CO)Diagnostic test
Expired carbon monoxide (CO) measurement
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Ecological Momentary Assessment (EMA); Biological: Biological assessment; Behavioral: Psychological examination and Substance Use symptomatology; Other: Treatment as usual (TAU); Diagnostic Test: Expired carbon monoxide (CO) |
| Treatment as usual | Other | Not described Receives: Biological: Biological assessment; Behavioral: Psychological examination and Substance Use symptomatology; Other: Treatment as usual (TAU); Diagnostic Test: Expired carbon monoxide (CO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expired carbon monoxide (CO) rate
Prevalence tobacco abstinence (Expired CO ≤ 8 ppm) 6 months after acute ward discharge.
Measured: 6 months
Secondary outcomes (36)
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). It consists of 8 questions covering tobacco, alcohol, cannabis, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opiates, and 'other drugs. Twenty-eight domains/scores are derived from these questions
Measured: Day 0
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). It consists of 8 questions covering tobacco, alcohol, cannabis, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opiates, and 'other drugs. Twenty-eight domains/scores are derived from these questions
Measured: 3 Months
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). It consists of 8 questions covering tobacco, alcohol, cannabis, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opiates, and 'other drugs. Twenty-eight domains/scores are derived from these questions
Measured: 6 Months
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). It consists of 8 questions covering tobacco, alcohol, cannabis, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opiates, and 'other drugs. Twenty-eight domains/scores are derived from these questions
Measured: 12 Months
Fagerström Test for Nicotine Dependence (FTND) score
Nicotine dependence using the Fagerström Test for Nicotine Dependence (FTND) which includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity.
Measured: Day 0
Fagerström Test for Nicotine Dependence (FTND) score
Nicotine dependence using the Fagerström Test for Nicotine Dependence (FTND) which includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity.
Measured: 3 months
Fagerström Test for Nicotine Dependence (FTND) score
Nicotine dependence using the Fagerström Test for Nicotine Dependence (FTND) which includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity.
Measured: 6 months
Fagerström Test for Nicotine Dependence (FTND) score
Nicotine dependence using the Fagerström Test for Nicotine Dependence (FTND) which includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity.
Measured: 12 months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Includes one question to assess each of the 11 DSM 5 diagnostic criteria for SRADs transposed to food items as well as two questions to assess clinically significant distress and impairment. Food Addiction is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress.
Measured: Day 0
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Includes one question to assess each of the 11 DSM 5 diagnostic criteria for SRADs transposed to food items as well as two questions to assess clinically significant distress and impairment. Food Addiction is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress.
Measured: 3 Months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Includes one question to assess each of the 11 DSM 5 diagnostic criteria for SRADs transposed to food items as well as two questions to assess clinically significant distress and impairment. Food Addiction is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress.
Measured: 6 Months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Includes one question to assess each of the 11 DSM 5 diagnostic criteria for SRADs transposed to food items as well as two questions to assess clinically significant distress and impairment. Food Addiction is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress.
Measured: 12 Months
Alcohol Use Disorder Identification Test (AUDIT) Score
Alcohol dependence test. 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, and above 12 = extreme severity for both sexes.
Measured: Day 0
Alcohol Use Disorder Identification Test (AUDIT) Score
Alcohol dependence test. 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, and above 12 = extreme severity for both sexes.
Measured: 3 months
Alcohol Use Disorder Identification Test (AUDIT) Score
Alcohol dependence test. 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, and above 12 = extreme severity for both sexes.
Measured: 6 months
Alcohol Use Disorder Identification Test (AUDIT) Score
Alcohol dependence test. 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, and above 12 = extreme severity for both sexes.
Measured: 12 months
Cannabis Abuse Screening Test (CAST) score
6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, and 3 or more = high risk of dependence.
Measured: Day 0
Cannabis Abuse Screening Test (CAST) score
6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, and 3 or more = high risk of dependence.
Measured: 3 Months
Cannabis Abuse Screening Test (CAST) score
6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, and 3 or more = high risk of dependence.
Measured: 6 Months
Cannabis Abuse Screening Test (CAST) score
6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, and 3 or more = high risk of dependence.
Measured: 12 Months
Readiness Ruler or Substance Use Motivation Ruler score
Asks the respondent to rank his/her motivation to end his/her substance use on a Visual Analog Scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations. The participant will be instructed to provide at least one motivation or more if relevant.
Measured: Day 0
Readiness Ruler or Substance Use Motivation Ruler score
Asks the respondent to rank his/her motivation to end his/her substance use on a Visual Analog Scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations. The participant will be instructed to provide at least one motivation or more if relevant.
Measured: 3 months
Readiness Ruler or Substance Use Motivation Ruler score
Asks the respondent to rank his/her motivation to end his/her substance use on a Visual Analog Scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations. The participant will be instructed to provide at least one motivation or more if relevant.
Measured: 6 months
Readiness Ruler or Substance Use Motivation Ruler score
Asks the respondent to rank his/her motivation to end his/her substance use on a Visual Analog Scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations. The participant will be instructed to provide at least one motivation or more if relevant.
Measured: 12 months
Hospital Anxiety and Depression scale (HAD) score
assesses the perceived level of depressive (7 items) and anxiety (7 items). For each subscale, a score of 7 or more is considered indexing depression and anxiety caseness.
Measured: Day 0
Hospital Anxiety and Depression scale (HAD) score
assesses the perceived level of depressive (7 items) and anxiety (7 items). For each subscale, a score of 7 or more is considered indexing depression and anxiety caseness.
Measured: 3 Months
Hospital Anxiety and Depression scale (HAD) score
assesses the perceived level of depressive (7 items) and anxiety (7 items). For each subscale, a score of 7 or more is considered indexing depression and anxiety caseness.
Measured: 6 Months
Hospital Anxiety and Depression scale (HAD) score
assesses the perceived level of depressive (7 items) and anxiety (7 items). For each subscale, a score of 7 or more is considered indexing depression and anxiety caseness.
Measured: 12 Months
Multidimensional Assessment of Thymic States scale (MAThYS) Score
visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped into five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. Motivation, and 5. sensory perception
Measured: Day 0
Multidimensional Assessment of Thymic States scale (MAThYS) Score
visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped into five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. Motivation, and 5. sensory perception
Measured: 3 Months
Multidimensional Assessment of Thymic States scale (MAThYS) Score
visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped into five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. Motivation, and 5. sensory perception
Measured: 6 Months
Multidimensional Assessment of Thymic States scale (MAThYS) Score
visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped into five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. Motivation, and 5. sensory perception
Measured: 12 Months
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
standardized instrument that includes 13 cognitive items, 9 emotional items, and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. The scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).
Measured: Day 0
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
standardized instrument that includes 13 cognitive items, 9 emotional items, and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. The scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).
Measured: 3 Months
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
standardized instrument that includes 13 cognitive items, 9 emotional items, and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. The scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).
Measured: 6 Months
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
standardized instrument that includes 13 cognitive items, 9 emotional items, and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. The scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start25 Mar 2025
- Primary completion25 Mar 2027 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor SIBON, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837311
- Sponsor's protocol ID
- CHUBX 2023/74
- Acronym
- PSDM
- Status last verified
- Jul 2025
- First submitted
- 4 Feb 2025
- Last updated
- 21 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Benefit of Digital Monitoring Using apTeleCare for Secondary Prevention in Patients With a Recent Transient Ischemic Attack or Stroke
- ClinicalTrials.gov ID
- NCT06837311
- Acronym / sponsor ID
- PSDM / CHUBX 2023/74
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the second leading cause of death and a major cause of disability worldwide. In 2019, Disability-Adjusted Life-Years (DALYs) related to stroke was estimated to have reached 143 million. Modifiable stroke risk-factors, which include poor lifestyle habits (tobacco, alcohol and illicit drug abuse, dietary patterns at risk, low physical activity), account for 90 % of the risk of stroke. Stroke complications and the risk of stroke recurrence is highly dependent on the control of these risk factors. Thus, the secondary prevention of stroke requires profound lifestyle modifications including substance use cessation and diet changes. National guidelines for stroke clinical practice advocate an immediate cessation of consumption of all substances but without recommendations on specific therapeutic regimens. Moreover, none address the management of poor coping with stress or mood problems though they are major population attributable risk factors of stroke and constitute major barriers of behavior changes achievement. Yet, post-stroke emotional impairments are frequent, post-stroke depression and anxiety being the most frequent (prevalence is 30% and 25%, respectively). Importantly, independently from stroke, emotional impairments or disorders and Substance Related and Addiction Disorders (SRADs) are frequent comorbid conditions (dual disorders) with debilitating consequences and the interplay between the two conditions makes rehabilitation more complex. This suggests that taking into account stroke patients' mental health status might improve not only the management of post-stroke emotional impairments but also the control of stroke vascular risk factors.
Regarding secondary prevention programs focusing on behavioral changes among Cardiovascular and Cerebrovascular Disease (CVD) patients, the literature is sparse and studies on smoking cessation are the most widely documented. Despite the risk of smoking after a myocardial infarct or a stroke/Transient Ischemic Attack (TIA), less than half of patients quit smoking after the event or achieve long-term abstinence.
To increase treatment adherence and efficacy, besides systematically screening lifestyle habits and evaluating the patients' mental health and motivation to change in clinical routine, experts in the domain emphasize the need to:
- start delivering treatment as early as possible, ideally during hospitalization;
- tailor the intensity of the treatment (combination of pharmacological medications +/- behavioral intervention; frequency of the follow-up/contacts) according to the risk profile of each patient, particularly depending on the level of dependence and the presence of comorbid emotional difficulties/psychiatric disorders.
After hospital discharge, in standard care, the follow-up visit is scheduled 4 to 6 months post-stroke. Knowing that the vast majority of smoking relapses occur in the weeks following stroke, it appears that this period is of high risk for missing the goal of stroke secondary prevention. Therefore, new approaches are urgently needed that would allow for the day-to-day examination of clinical change in the immediate days and weeks following discharge from the stroke acute-care unit to optimize the patient's recovery and quality of life.
The potential pivotal role of eHealth development has been advocated by the World Health Organization, which considers e-Health as a cost-effective and secure use of information and communication technologies (ICT). Used in the context of stroke secondary prevention, eHealth technologies should give each patient the opportunity to describe his/her own experiences and symptoms and the contexts of daily life in which they occur that may constitute negative factors for post-stroke recovery. Post-stroke management would thus be optimized through a person-centered, intense and multidisciplinary care program.
Investigators believe apTeleCare would allow for such a day-to-day examination of clinical change in the immediate days and weeks following discharge from the stroke acute-care unit. It offers the possibility not only to closely monitor patients' experiences and symptoms and the contexts of daily life in which they occur, but also to inform the clinical team in real-time via specific alerts that depend on the type and level of difficulties the patients encounter for adopting the expected changes in their lifestyle
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Ecological Momentary Assessment (EMA), Biological: Biological assessment, Behavioral: Psychological examination and Substance Use symptomatology, Other: Treatment as usual (TAU), Diagnostic Test: Expired carbon monoxide (CO) |
| Treatment as usual | Other | Biological: Biological assessment, Behavioral: Psychological examination and Substance Use symptomatology, Other: Treatment as usual (TAU), Diagnostic Test: Expired carbon monoxide (CO) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female
- At least 18 years of age and younger than 80 years;
- Recent (≤ 15 days) clinically symptomatic ischemic or hemorrhagic stroke documented through brain imaging (CT or MRI) or a Transient Ischemic Attack with an Predictive Risk Score (ABCD2) ≥ 4;
- Returning to the neurovascular unit for the standard care post-stroke follow-up visits;
- National Institute Health Stroke Scale (NIHSS) < 15;
Key exclusion criteria (11 listed)
- Subarachnoid hemorrhage; Dementia syndrome or other central neurologic disorder;
- Severe aphasia (NIHSS item 9 ≥ 2)
- Severe visual impairment interfering with the completion of evaluations;
- Severely impaired physical and/or mental health that, according to the neurologist, may affect the participant's capacity to participate in the study;
- Individuals already undergoing treatment for tobacco cessation and/or SRADs at admission in the stroke unit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary Assessment (EMA)Daily ecological momentary assessment (EMA), in addition to treatment as usual (TAU) using apTeleCare eHealth device. Daily surveys includes questions reflecting all Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 symptom criteria for Depression, Generalized Anxiety Disorder, Post-Traumatic Symptom Disorder, evaluations of substance use (including dietary items at risk) as well as of two symptoms predictive of relapse (craving and loss of control), medication compliance and physical activity | Device | Intervention |
| Biological assessmentRoutine Biological assessment and of substance use | Biological | Intervention, Treatment as usual |
| Psychological examination and Substance Use symptomatologySubstance use symptomatology ; Neuropsychiatric symptomatology ; Functional outcomes ; Neurologic and Cardiovascular outcomes | Behavioural | Intervention, Treatment as usual |
| Treatment as usual (TAU)Treatment as usual (TAU) | Other | Intervention, Treatment as usual |
| Expired carbon monoxide (CO)Expired carbon monoxide (CO) measurement | Diagnostic test | Intervention, Treatment as usual |
Primary outcome
Expired carbon monoxide (CO) rate
Time frame: 6 months
Prevalence tobacco abstinence (Expired CO ≤ 8 ppm) 6 months after acute ward discharge.
36 secondary outcomes
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Time frame: Day 0
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Time frame: 3 Months
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Time frame: 6 Months
Level of risk and prevalence of Substance-related and addictive disorders (SRADs)
Time frame: 12 Months
Fagerström Test for Nicotine Dependence (FTND) score
Time frame: Day 0
Fagerström Test for Nicotine Dependence (FTND) score
Time frame: 3 months
Fagerström Test for Nicotine Dependence (FTND) score
Time frame: 6 months
Fagerström Test for Nicotine Dependence (FTND) score
Time frame: 12 months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Time frame: Day 0
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Time frame: 3 Months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Time frame: 6 Months
modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) score
Time frame: 12 Months
Alcohol Use Disorder Identification Test (AUDIT) Score
Time frame: Day 0
Alcohol Use Disorder Identification Test (AUDIT) Score
Time frame: 3 months
Alcohol Use Disorder Identification Test (AUDIT) Score
Time frame: 6 months
Alcohol Use Disorder Identification Test (AUDIT) Score
Time frame: 12 months
Cannabis Abuse Screening Test (CAST) score
Time frame: Day 0
Cannabis Abuse Screening Test (CAST) score
Time frame: 3 Months
Cannabis Abuse Screening Test (CAST) score
Time frame: 6 Months
Cannabis Abuse Screening Test (CAST) score
Time frame: 12 Months
Readiness Ruler or Substance Use Motivation Ruler score
Time frame: Day 0
Readiness Ruler or Substance Use Motivation Ruler score
Time frame: 3 months
Readiness Ruler or Substance Use Motivation Ruler score
Time frame: 6 months
Readiness Ruler or Substance Use Motivation Ruler score
Time frame: 12 months
Hospital Anxiety and Depression scale (HAD) score
Time frame: Day 0
Hospital Anxiety and Depression scale (HAD) score
Time frame: 3 Months
Hospital Anxiety and Depression scale (HAD) score
Time frame: 6 Months
Hospital Anxiety and Depression scale (HAD) score
Time frame: 12 Months
Multidimensional Assessment of Thymic States scale (MAThYS) Score
Time frame: Day 0
Multidimensional Assessment of Thymic States scale (MAThYS) Score
Time frame: 3 Months
Multidimensional Assessment of Thymic States scale (MAThYS) Score
Time frame: 6 Months
Multidimensional Assessment of Thymic States scale (MAThYS) Score
Time frame: 12 Months
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
Time frame: Day 0
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
Time frame: 3 Months
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
Time frame: 6 Months
Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) score
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvie BERTHOZ contact
Igor SIBON principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Assessment (EMA), Biological assessment and Psychological examination and Substance Use symptomatology in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor SIBON (0556795520, igor.sibon@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expired carbon monoxide (CO) rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2025.