- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03752697
Metacognition in Neurological Injury
January 10, 2024 updated by: University of Nebraska Lincoln
Longitudinal Examination of Metacognition in Neurological Samples
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kathy Chiou, Ph.D.
- Phone Number: 402-472-5843
- Email: kchiou2@unl.edu
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68588-0308
- Recruiting
- University of Nebraska-Lincoln
-
Contact:
- Kathy Chiou, Ph.D.
- Phone Number: 402-472-5843
- Email: kchiou2@unl.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
participants in rehabilitation facility and community-dwelling individuals
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neurological injury
Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.
|
Paper and pencil/computerized tests of metacognition
|
Healthy control
Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.
|
Paper and pencil/computerized tests of metacognition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathy Chiou, Ph.D., University of Nebraska Lincoln
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2018
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
September 25, 2018
First Submitted That Met QC Criteria
November 21, 2018
First Posted (Actual)
November 26, 2018
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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