Validity of a Test of Functional Cognition in Persons Wit... | NCT04943835

Studies
Validity of a Test of Functional Cognition in Persons With Acquired Brain Injury

NCT04943835

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Jun 29, 2021Actual

Enrollment

73Actual

Phase

Not provided

Conditions

Acquired Brain Injury

Interventions

Observational - No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2017Actual

Primary Completion Date

Feb 5, 2020Actual

Completion Date

Feb 5, 2020Actual

First Submitted Date

Jun 22, 2021

First Submission Date that Met QC Criteria

Jun 22, 2021

First Posted Date

Jun 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2021

Last Update Posted Date

Jun 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The purpose of this study is to test the validity of the Weekly Calendar Planning Activity (WCPA), a test of functional cognition in persons with acquired brain injury. We will formally examine the utility, baseline profile and validity of the WCPA with adults ages 21 and above with acquired brain injury for both the WCPA 17 and WCPA 10 versions. The Weekly Calendar Planning Activity (WCPA) is a performance-based Cognitive Instrumental activities of daily living (C-IADL) task that requires working memory, planning, shifting, inhibition, and self-monitoring. The WCPA requires the examinee to input a series of 10 appointments, into a mock weekly calendar/schedule while following multiple rules, managing appointment conflicts, ignoring distracting questions by the examiner and keeping track of time. The WCPA is used routinely by occupational therapists for those with acquired brain injury, during their stay on the inpatient rehabilitation unit, prior to discharge as a measure of IADL. Persons who are currently receiving occupational therapy and would typically be given the WCPA within the course of routine occupational therapy, will be asked for permission to include their results within a database for the project. Persons who are alert, oriented x3, able to attend for at least 10 minutes, are able to read and write legibly in English would typically be administered the WCPA. Potential participants will be identified by their primary therapist. If the person does not provide consent, the WCPA will be administered as part of usual care but the results will not be included within the project.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Name	Type	Description	Arm Group Labels	Other Names
Observational - No intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WCPA Percent Accuracy	The Weekly Calendar Planning Activity (WCPA) is a performance-based Cognitive Instrumental activities of daily living (C-IADL) task that requires working memory, planning, shifting, inhibition, and self-monitoring. The WCPA requires the examinee to input a series of 10 appointments, into a mock weekly calendar/schedule while following multiple rules, managing appointment conflicts, ignoring distracting questions by the examiner and keeping track of time. WCPA percent accuracy is the number of appointments entered correctly out of 10.	During hospitalization, approximately one week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to attend for at least 10 minutes
Able to read and write legibly in English

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Persons with acquired brain injury receiving inpatient occupational therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael O'Dell, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medicine		New York	New York	10065	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided