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

NCT04087486 | Unknown

• 1 other identifier: CliniqueRR-07
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

Multiple errands tests

Outcome Measures

Primary Outcomes (1)

• Evaluation of the feasibility of the test.

  Is it suitable for TBI patients?

  2020

Secondary Outcomes (3)

• Evaluation of the criterion validity of the TEM-PRO

  2020

• Comparaison of the diagnostic value of the TEM-PRO with the classical Neuropsychological test and the TEM.

  2020

• Evaluation of the association between RTW and TEM-PRO

  2022

Interventions

Implementation of a behavioural test for patients with TBI DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clinique Romande de Readaptation: lead

Study Sites (1)

Clinique romande de réadaptation

Sion, Valais, 1951, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andreas Mühl, MD

  Clinique romande de réadaptation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: January 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: March 30, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

CH (1)