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

NCT04746716 | Unknown

• 1 other identifier: APHP201206
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Keywords

mTBI; prognosis; rehabilitation; long term results

Outcome Measures

Primary Outcomes (1)

• Evaluation of the long term results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

  quality of life questionnaire QOLIBRI (Quality of Life after Brain Injury). The QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions to assess health-related quality of life. Each items has to ba scaled from 1 (Not at all affected) to 5 (Very).The subscale scores can be used separately, or can be combined to give a profile of quality of life. All item responses can also be summed to give a total score.

  At inclusion = Day 1

Secondary Outcomes (3)

• Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury

  At inclusion = Day 1

• Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury

  At inclusion = Day 1

• Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury

  At inclusion = Day 1

Study Arms (2)

Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

Patient who had a psychoeducation and Cognitive Rehabilitation After their Mild Traumatic Brain Injury

Other: Phone call

No Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

Patient who hadn't a psychoeducation and Cognitive Rehabilitation After their Mild Traumatic Brain Injury

Other: Phone call

Interventions

Phone call OTHER

Phone call to the patient to complete quality of life scales

No Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury; Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

Eligibility Criteria

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

Study Population

80 mild traumatic brain injured patients included in our previous study (NCT03811626)will be contacted by phone

You may qualify if:

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

You may not qualify if:

• Patient without social security

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Nozar AGHAKHANI

CONTACT

33 1 45 21 23 80; nozar.aghakhani@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: February 10, 2021
• Study Start: March 2, 2021
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)