Early-phase Telecare Programs for Minor Stroke (COGaDOM)

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Minor Stroke

Treatments: Behavioral: Psychoeducation; Behavioral: Usual Care; Behavioral: Computerised Cognitive Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06306144

69HCL23_0691

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Patients receiving the Psychoeducation Intervention

Experimental group

Description:

Patients will participate in a 6-week psychoeducation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of exercises set by the rehabilitation clinician

Treatment:

Behavioral: Psychoeducation

Patients receiving the Computerised Cognitive Stimulation Intervention

Experimental group

Description:

Patients will participate in a 6-week cognitive stimulation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of on-line exercises set by the rehabilitation clinician.

Treatment:

Behavioral: Computerised Cognitive Stimulation

Patients receiving the Usual Care

Experimental group

Description:

Patients randomized to this group will complete the questionnaires and the cognitive tests but will receive no intervention

Treatment:

Behavioral: Usual Care