Clinical trial NCT04087486: Validation of an Ecological Organization and Problem Solving Test (TEM-PRO) in Vocational Rehabilitation
Official title: Validation of an Ecological Organization and Problem Solving Test (TEM-PRO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TBI (Traumatic Brain Injury)
Keywords: Multiple errands tests
Lead sponsor: Clinique Romande de Readaptation
Sponsor class: NETWORK
First posted: 2019-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a moderate to severe traumatic brain injury returning to work

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.

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of the feasibility of the test.
timeFrame: 2020
Secondary outcomes:
measure: Evaluation of the criterion validity of the TEM-PRO
timeFrame: 2020
measure: Comparaison of the diagnostic value of the TEM-PRO with the classical Neuropsychological test and the TEM.
timeFrame: 2020
measure: Evaluation of the association between RTW and TEM-PRO
timeFrame: 2022
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Clinique romande de réadaptation
state: Valais
Study officials:
affiliation: Clinique romande de réadaptation
name: Andreas Mühl, MD
role: PRINCIPAL_INVESTIGATOR
References: