TBI (Traumatic Brain Injury)TEM-PRONCT04087486
Validation of an Ecological Organization and Problem Solving Test (TEM-PRO) in Vocational Rehabilitation
An observational study of TBI (Traumatic Brain Injury), run by Clinique Romande de Readaptation at 1 site in Switzerland.
Trial summary
Standard neuropsychological evaluations after severe TBI (traumatic brain injury) often minimizes the executive deficits, these latter are known to seriously impair return to work. Therefore, we developed an ecological organization and problem-solving test in a vocational setting called the TEM-PRO. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Implementation of a behavioural test for patients with TBI
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2019to 30 Mar 2023
- 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: Patients with a moderate to severe traumatic brain injury returning to work
Who may be able to join
- French speaking patients, older than 18 years, able to understand and sign the study informed consent, able to answer questionnaires used in the study, suffering from moderate to severe TBI, without invalidate psychiatric comorbidities, without severe memory impairment, capable to participate for 4h in a vocational activity, planning to return to work. Patients still receiving compensation and patients returned to work will be included
Who cannot join
- alcohol or drug abuse, severe physical disability interfering with the test (modified Ranking score >1), under legal custody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of an Ecological Organization and Problem Solving Test (TEM-PRO)
Standard neuropsychological evaluations after severe TBI (traumatic brain injury) often minimizes the executive deficits, these latter are known to seriously impair return to work. Therefore, we developed an ecological organization and problem-solving test in a vocational setting called the TEM-PRO. The test consists of 4 activities of variable complexity, collection and redaction of information and demands to follow well defined rules.
Read the detailed description
While there may be many reasons for obtaining neuropsychological assessement after TBI, predication of the real world functioning is generally the final goal. Among the cognitive deficits, the dysexecutive syndrome is certainly the most disabling in impeding to return to work. The classical neuropsychological tests often fail to asses theses deficits adequately. Several more ecological tests have been previously developed. Based on the multiple errands test and the six elements test, we built up first an ecological test over 60 minutes for activities of the daily living (test des errances multiples, " TEM, version CRR "). Used regularly in the clinical setting, it was able to evaluate the functional aptitudes of the patients and was useful to complete the classical neuropsychological tests. However test duration is too short and activities are far away from real work scenarios to test working aptitudes. Therefore we developed a new executive-ecological test in a vocational setting (TEM-PRO). The adaptation of the original test in a vocational setting induces the addition of 4 activities of variable complexity, research and redaction of information and demands to follow well defined rules. Skills that are solicited are planning, selective and sustained attention, prospective memory, organization, problems solving and behavior adaption over a long period of time. Based on a pilot study with patients without neurological deficit we assessed that our test displayed good sensitivity without ceiling effect. It allowed a quantitative and differentiated evaluation, a classification of various error types (interpretation and judgment failure, rule breaks, task failures and inefficiencies) and provided a qualitative behavioral analysis.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Implementation of a behavioural test for patients with TBI
- Keywords
- Multiple errands tests
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a behavioural test for patients with TBIDiagnostic test
The following data will be collected: (1) sociodemographic variables (2); clinical and psychological data; (3) functional tests (neuropsychological testing, TEM version CRR and TEM-PRO).
On day one, patients will undergo standard neuropsychological tests and questionnaires listed hereafter, which are commonly used in the clinical practice at the CRR.
- The Patient Competency Rating Scale (PCRS)
- TEM (Multiple errands test)
- GREFEX
- 5 POINTS TEST
- TAP 2.3
- Behavioral Assessment of the Dysexecutives Syndrome (BADS)
On day two, the patients will perform the TEM-PRO test ambulatory in our vocation rehabilitation unit.
"Predictors" variables will be collected before testing: Sociodemographic: age, sex, education, marital status, mother language, time since TBI, severity of the TBI (moderate or severe), type of lesion (contusion, diffuse axonal injury grade 1-3, ischemic or other complications), history of TBI, stroke or meningitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the feasibility of the test.
Is it suitable for TBI patients?
Measured: 2020
Secondary outcomes (3)
Evaluation of the criterion validity of the TEM-PRO
Evaluation of the reproducibility of the test
Measured: 2020
Comparaison of the diagnostic value of the TEM-PRO with the classical Neuropsychological test and the TEM.
Comparison with existing tests
Measured: 2020
Evaluation of the association between RTW and TEM-PRO
Can the test be a predictor of RTW?
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Jan 2019
- Primary completion31 Jul 2022
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Romande de Readaptation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andreas Mühl, MD, Principal investigator, Clinique romande de réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087486
- Sponsor's protocol ID
- CliniqueRR-07
- Acronym
- TEM-PRO
- Status last verified
- Oct 2022
- First submitted
- 10 Sep 2019
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Ecological Organization and Problem Solving Test (TEM-PRO)
- ClinicalTrials.gov ID
- NCT04087486
- Acronym / sponsor ID
- TEM-PRO / CliniqueRR-07
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- Multiple errands tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinique Romande de ReadaptationResearch network
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 12 Sep 2019 (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.
Standard neuropsychological evaluations after severe TBI (traumatic brain injury) often minimizes the executive deficits, these latter are known to seriously impair return to work. Therefore, we developed an ecological organization and problem-solving test in a vocational setting called the TEM-PRO. The test consists of 4 activities of variable complexity, collection and redaction of information and demands to follow well defined rules.
Detailed description
While there may be many reasons for obtaining neuropsychological assessement after TBI, predication of the real world functioning is generally the final goal. Among the cognitive deficits, the dysexecutive syndrome is certainly the most disabling in impeding to return to work. The classical neuropsychological tests often fail to asses theses deficits adequately. Several more ecological tests have been previously developed. Based on the multiple errands test and the six elements test, we built up first an ecological test over 60 minutes for activities of the daily living (test des errances multiples, " TEM, version CRR "). Used regularly in the clinical setting, it was able to evaluate the functional aptitudes of the patients and was useful to complete the classical neuropsychological tests. However test duration is too short and activities are far away from real work scenarios to test working aptitudes. Therefore we developed a new executive-ecological test in a vocational setting (TEM-PRO). The adaptation of the original test in a vocational setting induces the addition of 4 activities of variable complexity, research and redaction of information and demands to follow well defined rules. Skills that are solicited are planning, selective and sustained attention, prospective memory, organization, problems solving and behavior adaption over a long period of time. Based on a pilot study with patients without neurological deficit we assessed that our test displayed good sensitivity without ceiling effect. It allowed a quantitative and differentiated evaluation, a classification of various error types (interpretation and judgment failure, rule breaks, task failures and inefficiencies) and provided a qualitative behavioral analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a moderate to severe traumatic brain injury returning to work
Key inclusion criteria (1 listed)
- French speaking patients, older than 18 years, able to understand and sign the study informed consent, able to answer questionnaires used in the study, suffering from moderate to severe TBI, without invalidate psychiatric comorbidities, without severe memory impairment, capable to participate for 4h in a vocational activity, planning to return to work. Patients still receiving compensation and patients returned to work will be included
Key exclusion criteria (1 listed)
- alcohol or drug abuse, severe physical disability interfering with the test (modified Ranking score >1), under legal custody.
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 |
|---|---|---|
| Implementation of a behavioural test for patients with TBIThe following data will be collected: (1) sociodemographic variables (2); clinical and psychological data; (3) functional tests (neuropsychological testing, TEM version CRR and TEM-PRO). On day one, patients will undergo standard neuropsychological tests and questionnaires listed hereafter, which are commonly used in the clinical practice at the CRR. * The Patient Competency Rating Scale (PCRS) * TEM (Multiple errands test) * GREFEX * 5 POINTS TEST * TAP 2.3 * Behavioral Assessment of the Dysexecutives Syndrome (BADS) On day two, the patients will perform the TEM-PRO test ambulatory in our vocation rehabilitation unit. "Predictors" variables will be collected before testing: Sociodemographic: age, sex, education, marital status, mother language, time since TBI, severity of the TBI (moderate or severe), type of lesion (contusion, diffuse axonal injury grade 1-3, ischemic or other complications), history of TBI, stroke or meningitis. | Diagnostic test | – |
Primary outcome
Evaluation of the feasibility of the test.
Time frame: 2020
Is it suitable for TBI patients?
3 secondary outcomes
Evaluation of the criterion validity of the TEM-PRO
Time frame: 2020
Comparaison of the diagnostic value of the TEM-PRO with the classical Neuropsychological test and the TEM.
Time frame: 2020
Evaluation of the association between RTW and TEM-PRO
Time frame: 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Caregivers
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.
Andreas Mühl, MD principal investigator
Clinique romande de réadaptation
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 TBI (Traumatic Brain Injury), run by Clinique Romande de Readaptation at 1 site in Switzerland.
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 1 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 1 Nov 2022. 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 Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the feasibility of the test. (time frame: 2020). 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 1 Nov 2022.