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

Mild Traumatic Brain Injury Clinical Trial

— ReLoT-TCCL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04746716
• Other study ID #: APHP201206
• Status: Not yet recruiting
• Start date: March 2, 2021
• Est. completion date: September 2, 2021

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nozar AGHAKHANI
• Phone: 33 1 45 21 23 80
• Email: nozar.aghakhani[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Phone call
Phone call to the patient to complete quality of life scales

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital	Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury	quality of life questionnaire SF-36 : The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study[1].; It comprises 36 questions which cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high quality of life	At inclusion = Day 1
Secondary	Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury	PCLS (Posttraumatic Stress Disorder Checklist Scale). 17 items rated from 1 (never) to 5 (Very often)	At inclusion = Day 1
Secondary	Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury	Professional Quality of Life Scale : The ProQOL has sub-scales for compassion satisfaction, burnout and compassion fatigue. There are 30questions rated from 1(Never) to 5(Very often)	At inclusion = Day 1