Clinical trial NCT06306144: Early-phase Telecare Programs for Minor Stroke
Official title: Mild Cognitive Impairment After Minor Stroke: Evaluation of Early-phase Telecare Programs (Psychoeducation and Computerized Cognitive Stimulation)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Minor Stroke
Keywords: cognitive complaint
computerized stimulation
psychoeducation
tele-rehabilitation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Minor strokes (few acute neurological symptoms ; NIHSS score \<5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation.

However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment.

Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Man or woman, aged between 18 and 65 years old
* Hospitalization for a first stroke
* Minor stroke: NIHSS score \< 5 on discharge from neurovascular unit
* Post-stroke delay \< 8 weeks
* Living at home (not institutionalized)
* Affiliated with social security or benefiting from such a scheme
* French language
* Presence of a cognitive complaint (FACT-Cog "perceived cognitive impairments" subscale score \< 55) and absence of major cognitive impairment
* Signature of informed consent

Exclusion Criteria:

* History of stroke
* Uncorrected hearing or visual impairment
* Neurological pathology other than stroke or disabling psychiatric disorder
* Unstabilized epilepsy
* Undergoing cognitive rehabilitation in another context or having integrated a post-stroke therapeutic education program
* Living in a white zone that does not allow for remote rehabilitation
* Unable to connect to the Internet
* Pregnant, parturient or breast-feeding women\* (interview data)
* Persons deprived of their liberty by judicial or administrative decision
* Persons admitted to a health or social institution for purposes other than research
* Adults under legal protection (guardianship, curatorship)
* Taking part in other interventional research involving a period of exclusion still in progress at pre-inclusion

Primary outcomes:
measure: The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke.
timeFrame: At the end of the study : 36 months
Secondary outcomes:
measure: to evaluate the effects on quality of life of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
measure: to evaluate the effects on cognitive complaint of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
measure: to evaluate the effects on cognitive function of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
measure: to evaluate the effects on mood and anxiety of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
measure: to evaluate the effects on fatigue of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
measure: to evaluate the effects on participation of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
timeFrame: At the end of the study : 36 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Lille
country: France
facility: CHU Lille
city: Saint-Genis-Laval
country: France
facility: Hôpital Henry Gabrielle
Study officials:
References: