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Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R

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ClinicalTrials.gov Identifier: NCT03126929
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ying Zhang, Hangzhou Normal University

Brief Summary:
This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).

Condition or disease Intervention/treatment
Minimally Conscious State Vegetative State Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

Detailed Description:
Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a systematic review of behavioral assessment scales for DOC has indicated that, when compared to other scales, the CRS-R meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess DOC with minor reservations. However, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.The report also states that the diagnostic validity of the CRS-R remains unproven. In this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with DOC

Study Type : Observational
Actual Enrollment : 169 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Further Psychometric Data for the Reliability and the Diagnostic Validity of the Coma Recovery Scale-Revised
Actual Study Start Date : March 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

Group/Cohort Intervention/treatment
Vegetative state
patients lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R and GCS
Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale
Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Minimally conscious state
Patients display inconsistent, but reproducible and discernible signs of awareness using CRS-R and GCS
Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale
Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Emergence from MCS
Patients regain accurate communication and/or functional use of objects using CRS-R and GCS
Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale
Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)




Primary Outcome Measures :
  1. Coma Recovery Scale-Revised for assess the level of consciousness [ Time Frame: 24 hours(1 day) ]
    Rater Measured the score of Coma Recovery Scale-Revised(CRS-R) within 24h. The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The lowest item on each subscale represents reflexive activity while the highest items represent cognitively-mediated behaviors.



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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators chosen patients with VS, MCS, EMCS
Criteria

Inclusion Criteria:

  • age above 18 years old
  • any etiology
  • pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)

Exclusion Criteria:

  • neuromuscular blocking agents or sedative drugs administered within the prior 24 hours
  • no documented history of a prior coma
  • critical illness or unstable medical condition

Responsible Party: Ying Zhang, nurse-in-charge, Hangzhou Normal University
ClinicalTrials.gov Identifier: NCT03126929     History of Changes
Other Study ID Numbers: 2012/026/B
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ying Zhang, Hangzhou Normal University:
disorders of consciousness
Vegetative state
Minimally conscious state
Emergence from MCS
Coma Recovery Scale-Revised

Additional relevant MeSH terms:
Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms