Clinical Trials Directory

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UnknownNCT04746716

Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

Status
Unknown
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPhone callPhone call to the patient to complete quality of life scales

Timeline

Start date
2021-03-02
Primary completion
2021-09-02
Completion
2021-09-02
First posted
2021-02-10
Last updated
2021-03-02

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04746716. Inclusion in this directory is not an endorsement.