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ENROLLING BY INVITATION
NCT06850857

Multi-Institutional IMPACT Validation

Sponsor: University of Tennessee

View on ClinicalTrials.gov

Summary

The goal of this observational study is to validate a novel patient-reported outcome measure (PROM) for patients suffering maxillofacial trauma: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT). The primary question is: Are the IMPACT modules valid and reliable measures to study quality-of-life (QOL) in patients with maxillofacial trauma? Patients presenting for routine clinic follow-up for maxillofacial trauma will be invited to complete the IMPACT in addition to the 15 Dimension (15D) QOL survey as a control.

Official title: Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2025-07-01

Completion Date

2026-12-31

Last Updated

2025-06-18

Healthy Volunteers

No

Interventions

OTHER

IMPACT-G Module

Administration of the general IMPACT survey module.

OTHER

IMPACT-N Module

Administration of the IMPACT-N survey module.

OTHER

IMPACT-O Module

Administration of the IMPACT-O survey module.

OTHER

IMPACT-J Module

Administration of the IMPACT-J survey module.

OTHER

15D Control Survey

Administration of the 15D QOL control survey.

Locations (3)

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Tennessee Health Science Center

Memphis, Tennessee, United States