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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04746716
Acronym
ReLoT-TCCL
Enrollment
80
Registered
2021-02-10
Start date
2021-03-02
Completion date
2021-09-02
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury

Keywords

mTBI, prognosis, rehabilitation, long term results

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.

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.

Interventions

OTHERPhone call

Phone call to the patient to complete quality of life scales

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the long term results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain InjuryAt inclusion = Day 1quality 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

MeasureTime frameDescription
Contribution of knowledge on the epidemiology of Mild Traumatic Brain InjuryAt inclusion = Day 1quality 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

Countries

France

Contacts

Primary ContactNozar AGHAKHANI
nozar.aghakhani@aphp.fr33 1 45 21 23 80

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026