A Prospective Chart Review to Validate the WFIRS (Weiss F... | NCT00885807

Studies
A Prospective Chart Review to Validate the WFIRS (Weiss Functional Impairment Rating Scale)

NCT00885807

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Jun 20, 2011Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Attention-Deficit/Hyperactivity Disorder

Interventions

Not provided

Countries

Canada

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 2011

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

Jul 2006

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Apr 20, 2009

First Submission Date that Met QC Criteria

Apr 21, 2009

First Posted Date

Apr 22, 2009Estimated

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 17, 2011

Last Update Posted Date

Jun 20, 2011Estimated

Name	Class
Eli Lilly and Company	INDUSTRY
Purdue Pharma LP	INDUSTRY
Shire	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of the study is to evaluate the psychometric validation of the Weiss Functional Impairment Rating Scale and the Weiss Symptom Record. It is hypothesized that the Weiss Functional Impairment Rating Scale has strong psychometric properties and good convergent validity with other measures of functioning and discriminant validity from symptoms and quality of life.

Detailed Description

The measures for this rating scale were developed at the request of the Canadian Attention Deficit Disorder Resource Alliance to provide clinician friendly tools free of charge as a way of improving screening for ADHD and comorbidity.

Patients are consented during clinic visits and agree to allow use of clinic data for the purpose of this research. They complete additional measure(s) for the purpose of the study. The data is then entered.

Internal consistency will be measured using Cronbach's alpha. Convergent, concurrent and discriminant validity will be measured using Pearson correlations. Domain reliability is determined with factor analysis. Up to 220 patients will be enrolled in the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

220Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Compliance to complete the WFIRS is key to inclusion.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

People with ADHD from 7 years of age

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Margaret D. Weiss, MD, Ph.D	University of British Columbia	Principal Investigator
Chistopher Gibbins, MD	BC Children's & Women's Hospital, Vancouver	Study Director
Grant Iverson, MD	University of British Columbia	Study Director
Brian Brooks, MD	BC Children's & Women's Hospital, Vancouver	Study Director
Li Ying Lu, MD	BC Children's & Women's Hospital, Vancouver	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Provincial ADHD Program, BC Children's & Women's Health Centre		Vancouver	British Columbia		Canada

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided