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

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ClinicalTrials.gov Identifier: NCT04746716
Recruitment Status : Not yet recruiting
First Posted : February 10, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment
Mild Traumatic Brain Injury 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 Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury
Estimated Study Start Date : March 2, 2021
Estimated Primary Completion Date : September 2, 2021
Estimated Study Completion Date : September 2, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the long term results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury [ Time Frame: At inclusion = Day 1 ]
    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.


Secondary Outcome Measures :
  1. Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury [ Time Frame: At inclusion = Day 1 ]

    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


  2. Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury [ Time Frame: At inclusion = Day 1 ]
    PCLS (Posttraumatic Stress Disorder Checklist Scale). 17 items rated from 1 (never) to 5 (Very often)

  3. Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury [ Time Frame: At inclusion = Day 1 ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
80 mild traumatic brain injured patients included in our previous study (NCT03811626)will be contacted by phone
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04746716


Contacts
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Contact: Nozar AGHAKHANI 33 1 45 21 23 80 nozar.aghakhani@aphp.fr

Locations
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France
AP-HP, Bicêtre Hospital
Le Kremlin Bicêtre, France, 94275
Contact: Nozar AGHAKHANI, MD, PhD    +33(0)1 45 21 23 80    nozar.aghakhani@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04746716    
Other Study ID Numbers: APHP201206
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
mTBI
prognosis
rehabilitation
long term results
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating