Post-Stroke Secondary Prevention With Digital Monitoring

NCT ID: NCT06837311

Last Updated: 2025-07-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2028-03-25

Brief 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. 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

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Ecological Momentary Assessment (EMA)

Intervention Type: 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 assessment

Intervention Type: BIOLOGICAL

Routine Biological assessment and of substance use

Psychological examination and Substance Use symptomatology

Intervention Type: BEHAVIORAL

Substance use symptomatology ; Neuropsychiatric symptomatology ; Functional outcomes ; Neurologic and Cardiovascular outcomes

Treatment as usual (TAU)

Intervention Type: OTHER

Treatment as usual (TAU)

Expired carbon monoxide (CO)

Intervention Type: DIAGNOSTIC_TEST

Expired carbon monoxide (CO) measurement

Treatment as usual

Group Type: OTHER

Biological assessment

Intervention Type: BIOLOGICAL

Routine Biological assessment and of substance use

Psychological examination and Substance Use symptomatology

Intervention Type: BEHAVIORAL

Substance use symptomatology ; Neuropsychiatric symptomatology ; Functional outcomes ; Neurologic and Cardiovascular outcomes

Treatment as usual (TAU)

Intervention Type: OTHER

Treatment as usual (TAU)

Expired carbon monoxide (CO)

Intervention Type: DIAGNOSTIC_TEST

Expired carbon monoxide (CO) measurement

Interventions

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

Intervention Type: DEVICE

Biological assessment

Routine Biological assessment and of substance use

Intervention Type: BIOLOGICAL

Psychological examination and Substance Use symptomatology

Substance use symptomatology ; Neuropsychiatric symptomatology ; Functional outcomes ; Neurologic and Cardiovascular outcomes

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

Treatment as usual (TAU)

Intervention Type: OTHER

Expired carbon monoxide (CO)

Expired carbon monoxide (CO) measurement

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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;
• 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

Exclusion Criteria

• 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;
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Igor SIBON

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Igor SIBON

Role: CONTACT

igor.sibon@chu-bordeaux.fr

0556795520

Sylvie BERTHOZ

Role: CONTACT

sylvie.berthoz-landron@inserm.fr

Facility Contacts

Igor SIBON

Role: primary

igor.sibon@chu-bordeaux.fr

05 56 79 55 20

Other Identifiers

CHUBX 2023/74

Identifier Type: -

Identifier Source: org_study_id