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Validation of an Ecological Organization and Problem Solving Test (TEM-PRO) in Vocational Rehabilitation (TEM-PRO)

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ClinicalTrials.gov Identifier: NCT04087486
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Clinique Romande de Readaptation

Brief 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. The test consists of 4 activities of variable complexity, collection and redaction of information and demands to follow well defined rules.

Condition or disease Intervention/treatment
TBI (Traumatic Brain Injury) Diagnostic Test: Implementation of a behavioural test for patients with TBI

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of an Ecological Organization and Problem Solving Test (TEM-PRO)
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Intervention Details:
  • Diagnostic Test: Implementation of a behavioural test for patients with TBI

    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.



Primary Outcome Measures :
  1. Evaluation of the feasibility of the test. [ Time Frame: 2020 ]
    Is it suitable for TBI patients?


Secondary Outcome Measures :
  1. Evaluation of the criterion validity of the TEM-PRO [ Time Frame: 2020 ]
    Evaluation of the reproducibility of the test

  2. Comparaison of the diagnostic value of the TEM-PRO with the classical Neuropsychological test and the TEM. [ Time Frame: 2020 ]
    Comparison with existing tests

  3. Evaluation of the association between RTW and TEM-PRO [ Time Frame: 2022 ]
    Can the test be a predictor of RTW?



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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
Patients with a moderate to severe traumatic brain injury returning to work
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

alcohol or drug abuse, severe physical disability interfering with the test (modified Ranking score >1), under legal custody.


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): NCT04087486


Contacts
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Contact: Bertrand Léger, PhD 27 603 2075 ext +41 bertrand.leger@crr-suva.ch

Locations
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Switzerland
Clinique romande de réadaptation Recruiting
Sion, Valais, Switzerland, 1951
Contact: Bertrand Léger, PhD    276032075 ext +41    bertrand.leger@crr-suva.ch   
Sponsors and Collaborators
Clinique Romande de Readaptation
Investigators
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Principal Investigator: Andreas Mühl, MD Clinique romande de réadaptation

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Responsible Party: Clinique Romande de Readaptation
ClinicalTrials.gov Identifier: NCT04087486     History of Changes
Other Study ID Numbers: CliniqueRR-07
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Clinique Romande de Readaptation:
Multiple errands tests
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries