Early-phase Telecare Programs for Minor Stroke
ConditionMinor Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospices Civils de Lyon
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of stroke
Uncorrected hearing or visual impairment
Neurological pathology other than stroke or disabling psychiatric disorder
Unstabilized epilepsy
Trial design
Design model
Parallel
Treatments tested in this trial
Psychoeducation
BehavioralArm 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.
Computerised Cognitive Stimulation
BehavioralArm 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
Usual Care
BehavioralArm 3 : No specific care.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Patients receiving the Psychoeducation InterventionExperimental treatment 1 intervention
Group B: Patients receiving the Computerised Cognitive Stimulation InterventionExperimental treatment 1 intervention
Group C: Patients receiving the Usual CareExperimental treatment 1 intervention
Trial outcomes
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
Time frame
At the end of the study : 36 monthsSecondary outcomes
1
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)
the effects of the proposed programs will be evaluated with quality of life measured using the WHOQOL-BREF Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame
At the end of the study : 36 months2
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)
the effects of the proposed programs will be evaluated with cognitive complaint measured using the FACT-Cog; Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame
At the end of the study : 36 months3
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)
the effects of the proposed programs will be evaluated with cognitive function (notably attentional, executive and memory functions) measured using a custom-designed battery of neuropsychological tests; Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame
At the end of the study : 36 months4
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)
the effects of the proposed programs on mood and anxiety will be measured by the HADS Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Time frame
At the end of the study : 36 monthsSponsors and contacts
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Source ClinicalTrials.gov
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