Early-phase Telecare Programs for Minor Stroke

NCT06306144 | Not Yet Recruiting

• 1 other identifier: 69HCL23_0691
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Minor Stroke

Keywords

cognitive complaint; computerized stimulation; psychoeducation; tele-rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Difference in the Participation score (from the Participation subscale of the stroke impact scale) between the pre-intervention evaluation and the evaluation 6 months post-stroke, between the intervention and non-intervention groups

  At the end of the study : 36 months

Secondary Outcomes (8)

• 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)

  At the end of the study : 36 months

• 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)

  At the end of the study : 36 months

• 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)

  At the end of the study : 36 months

• 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)

  At the end of the study : 36 months

• 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)

  At the end of the study : 36 months

Study Arms (3)

Patients receiving the Psychoeducation Intervention

EXPERIMENTAL

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

Behavioral: Psychoeducation

Patients receiving the Computerised Cognitive Stimulation Intervention

EXPERIMENTAL

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.

Behavioral: Computerised Cognitive Stimulation

Patients receiving the Usual Care

EXPERIMENTAL

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

Behavioral: Usual Care

Interventions

Psychoeducation BEHAVIORAL

Arm 1 : Psychoeducation aims to inform patients about post-stroke cognitive impairment, teach them coping strategies to compensate for these difficulties, provide information on symptom recognition and management, and offer emotional and psychological support to help them meet the challenges associated with these potential cognitive impairments.

Patients receiving the Psychoeducation Intervention

Computerised Cognitive Stimulation BEHAVIORAL

Arm 2 :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

Patients receiving the Computerised Cognitive Stimulation Intervention

Usual Care BEHAVIORAL

Arm 3 : No specific care.

Patients receiving the Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU Lille

Lille, 59037, France

Location

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location

Central Study Contacts

PUGNIET Virginie

CONTACT

04.78.86.50.64; virginie.pugniet@chu-lyon.fr

CHARLOIS Anne-Laure

CONTACT

04.78.86.50.64; anne-laure.charlois@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)