PFRONT - Prospective cohort study on early identification and treatment of adaptive deficits in mild to moderate traumatic brain injury - the impact of frontal network dysfunction for longterm outcome.

Completed

• Conditions: traumatisch hersenletsel; adaptive deficit; behavioral regulation; 10009841

• Registration Number: NL-OMON37031
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2200

Inclusion Criteria

Patients with mild to moderate TBI who are admitted to the emergency department of one of the participating hospitals. All patients admitted within the one-year inclusion period will be asked to participate in the follow up study.

Project 1 - GCS scores on admission from 9-15 with loss of consciousness or Posttraumatic Amnesia. Age >15 years. Comprehension of Dutch language.
Project 2 - Same as for study 1, but age range between 18-65 years. At least 3 complaints determined with a questionnaire 2 weeks postinjury comprising minimally one complaint in the cognitive domain and minimally one in the emotional/social domain (based on the actual incidence of PCS).
Project 3 - age range between 18-65 years.

Exclusion Criteria

Inability to follow-up, drug or alcohol abuse, psychiatric co-morbidity, previous TBI, language barriers prohibiting understanding and completion of questionnaires.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the intervention study the primary outcome measure is level of resumption<br /><br>of work or study 12 months, measured with the RTW subscale of the RRL (Van den<br /><br>Burg & van Zomeren, 1985). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Working status defined as total days off work at 12 months<br /><br>-GOS-E, determined by an experienced neurologist at 12 months<br /><br>-Differential Outcome Scale (DOS, van der Naalt, 2000), determined at 12 months<br /><br>-Role resumption (RRL; Rolhervattingslijst, Spikman et al, 2010) </p><br>