Mild Traumatic Brain InjuryReLoT-TCCLNCT04746716
Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury
An observational study of Mild Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Phone call
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2021to 2 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 mild traumatic brain injured patients included in our previous study (NCT03811626)will be contacted by phone
Who may be able to join
- all patients from our previous study NCT03811626 and included by our center
- Patient informed and willing to participate
Who cannot join
- Patient without social security
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, 94275
Nozar AGHAKHANI, MD, PhD, +33(0)1 45 21 23 80, nozar.aghakhani@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Phone call
- Keywords
- mTBI, prognosis, rehabilitation, long term results
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callOther
Phone call to the patient to complete quality of life scales
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury | Patient who had a psychoeducation and Cognitive Rehabilitation After their Mild Traumatic Brain Injury Receives: 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 Receives: Other: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion = Day 1
Secondary outcomes (3)
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
Measured: 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)
Measured: 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)
Measured: At inclusion = Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start2 Mar 2021 (estimated)
- Primary completion2 Sep 2021 (estimated)
- Study completion2 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746716
- Sponsor's protocol ID
- APHP201206
- Acronym
- ReLoT-TCCL
- Status last verified
- Feb 2021
- First submitted
- 19 Nov 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04746716
- Acronym / sponsor ID
- ReLoT-TCCL / APHP201206
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mTBI, prognosis, rehabilitation, long term results
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Mar 2021 (estimated)
- Primary completion
- 2 Sep 2021 (estimated)
- Study completion
- 2 Sep 2021 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury | – | Other: Phone callPatient who had a psychoeducation and Cognitive Rehabilitation After their Mild Traumatic Brain Injury |
| No Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury | – | Other: Phone callPatient who hadn't a psychoeducation and Cognitive Rehabilitation After their Mild Traumatic Brain Injury |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 mild traumatic brain injured patients included in our previous study (NCT03811626)will be contacted by phone
Key inclusion criteria (2 listed)
- all patients from our previous study NCT03811626 and included by our center
- Patient informed and willing to participate
Key exclusion criteria (1 listed)
- Patient without social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callPhone call to the patient to complete quality of life scales | Other | No Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury, Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury |
Primary outcome
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.
3 secondary outcomes
Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury
Time frame: At inclusion = Day 1
Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury
Time frame: At inclusion = Day 1
Contribution of knowledge on the epidemiology of Mild Traumatic Brain Injury
Time frame: At inclusion = Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nozar AGHAKHANI (33 1 45 21 23 80, nozar.aghakhani@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the long term results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury (time frame: At inclusion = Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.