Clinical trial NCT04746716: Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury
Official title: Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Traumatic Brain Injury
Keywords: mTBI
prognosis
rehabilitation
long term results
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 mild traumatic brain injured patients included in our previous study (NCT03811626)will be contacted by phone

Brief summary: Mild traumatic brain injury (mTBI) accounts for 70-90% of brain injuries, with 600 cases of mTBI per 100 000 people in the united states, but only 100-300 mTBI patients per 100 000 people receive hospital-based care. Symptoms reported immediately after injury tend to diminish over the following 10 days and are generally resolved by 3 months. However, in 15-25% of cases , problems persist, and may even worsen, at 3 months. Physical, emotional, and behavioral factors can be affected. Physical disorders include pain and fatigue. Sleep disorders are also common. Persistent symptoms can affect patient outcomes (affecting all aspects of life) and increase public healthcare costs .In a previous study (NCT03811626, Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. The investigators were able to demonstrate that early multidisciplinary management improved the outcome and prognosis of patients by statistically significantly reducing the percentage of patients with Post traumatic syndrome distress at six months (6% for the treated group versus 52% for the control group, p \< 0.001).

It seems important to verify that if this short-term improvement (6 months after the trauma) persists in the long term, and therefore at a distance from the end of the initially proposed rehabilitation.

Detailed description: 80 mTBI patients included in the previous study (NCT03811626) will be contacted by phone and an assessment consisting of questionnaires (QOLIBRI, SF-36, Posttraumatic stress disorder Checklist Scale (PCLS ) , ProQol) will be offered to them.

Eligibility criteria: Inclusion Criteria:

* all patients from our previous study NCT03811626 and included by our center
* Patient informed and willing to participate

Exclusion Criteria:

* Patient without social security

Primary outcomes:
measure: Evaluation of the long term results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury
timeFrame: At inclusion = Day 1
Secondary outcomes:
measure: Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury
timeFrame: At inclusion = Day 1
measure: Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury
timeFrame: At inclusion = Day 1
measure: Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury
timeFrame: At inclusion = Day 1
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
References: