Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury (ReLoT-TCCL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Other: Phone call

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Nozar AGHAKHANI; Phone Number: 33 1 45 21 23 80; Email: nozar.aghakhani@aphp.fr

Study Locations

• France
  • Le Kremlin Bicêtre, France, 94275
    • AP-HP, Bicêtre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Phone call to the patient to complete quality of life scales
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; Phone call to the patient to complete quality of life scales

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 2, 2021
• Primary Completion (ANTICIPATED): September 2, 2021
• Study Completion (ANTICIPATED): September 2, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (ACTUAL): February 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; mTBI; prognosis; long term results
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: APHP201206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No