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Metacognition in Neurological Injury

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ClinicalTrials.gov Identifier: NCT03752697
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nebraska Lincoln

Brief Summary:
The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. It is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.

Condition or disease Intervention/treatment
Brain Injuries Behavioral: metacognitive performance

Detailed Description:
This study will examine the trajectory of metacognitive functioning through different phases of recovery from neurological insult, and document its relationship to rehabilitation compliance. Individuals currently completing rehabilitation programs and individuals from the community who meet study criteria are invited to participate. After consenting and enrolling in the study, participants complete 2 study sessions: a baseline session, and a follow-up session either at time of completion of rehabilitation program or 3 months later if not in a rehabilitation program. During the study sessions, participants will complete paper-and-pencil and computerized tests of cognition (including metacognitive tasks).

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Examination of Metacognition in Neurological Samples
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
Neurological injury
Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.
Behavioral: metacognitive performance
Paper and pencil/computerized tests of metacognition

Healthy control
Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.
Behavioral: metacognitive performance
Paper and pencil/computerized tests of metacognition




Primary Outcome Measures :
  1. Change from baseline metamemory performance to completion of rehabilitation [ Time Frame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months) ]
    The computerized metamemory test produces scores that are used to calculate a gamma coefficient, which is a quantitative measure of the individual's metacognitive performance/accuracy.


Secondary Outcome Measures :
  1. Change in rehabilitative engagement [ Time Frame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months) ]
    The rehabilitative engagement questionnaire is a clinician-report measure that queries the clinician's perception of their client's participation in rehabilitation services.



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
participants in rehabilitation facility and community-dwelling individuals
Criteria

Inclusion Criteria:

  • history of brain and/or spinal cord injury
  • no history of brain or neurological injury/insult (for healthy control group)
  • fluent in spoken and written English
  • adequate gross motor abilities to provide a button push on a keyboard

Exclusion Criteria:

  • exclusion criteria for healthy controls include:
  • current/past history of psychiatric illness
  • learning disorder
  • developmental disorder
  • diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752697


Contacts
Contact: Kathy Chiou, Ph.D. 402-472-5843 kchiou2@unl.edu

Locations
United States, Nebraska
University of Nebraska-Lincoln Recruiting
Lincoln, Nebraska, United States, 68588-0308
Contact: Kathy Chiou, Ph.D.    402-472-5843    kchiou2@unl.edu   
Sponsors and Collaborators
University of Nebraska Lincoln
Investigators
Principal Investigator: Kathy Chiou, Ph.D. University of Nebraska Lincoln

Responsible Party: University of Nebraska Lincoln
ClinicalTrials.gov Identifier: NCT03752697     History of Changes
Other Study ID Numbers: 18123
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by University of Nebraska Lincoln:
metacognition
self-assessment

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries