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Validity and Feasibility of the CRSR-FAST

NCT03549572 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2024-10-26

Study results available
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Summary

The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. We have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.

Conditions

Interventions

BEHAVIORAL

Coma Recovery Scale-Revised

Patients will be assessed using the CRS-R and the CRSR-FAST. The CRS-R is a standardized neurobehavioral rating scale that consists of 23 items organized into six subscales that address arousal, auditory, visual, motor, oromotor/verbal, and communication systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors. Reliability and validity have been demonstrated in multiple studies. The CRSR-FAST consists of 10 items organized into 4 subscales that address arousal, visual, motor and verbal/oromotor systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2022-12-04
Completion
2022-12-04

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549572 on ClinicalTrials.gov