Functional Assessment Questionnaire for the Visually Challenged - Full Text View

Sponsor:	George Washington University
Information provided by:	George Washington University
ClinicalTrials.gov Identifier:	NCT00407901

Purpose

The purpose of this research is to evaluate how accurately a proposed "Functionality Assessment Questionnaire" measures the differences between low-functioning and high-functioning visually challenged individuals who are legally blind.

Condition
Blindness, Legal

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	Functional Assessment Questionnaire for the Visually Challenged: Proposed Model to Quantitatively Measure the Functional Level of Individuals Who Are Legally Blind

Further study details as provided by George Washington University:

Enrollment:	31
Study Start Date:	April 2006
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts
A, B A: High functioning visually challenged (legally blind) B: Low-functioning visually challenged (legally blind)

Detailed Description:

The specific aim of this research is to establish the scientific validity of an evaluation assessment tool that will measure the functional level of the visually challenged population. For this study a quantitative, self-evaluation tool has been designed to assess the functional skills at performing a variety of activities. It is called the Functional Assessment Questionnaire. The questionnaire is an innovative approach to measuring the level of these functional skills. It also includes critical benchmarks of real-world success that are not considered in assessing functional levels of the visually challenged, but are measures of evidence-based outcomes. It is a comprehensive measurement tool covering many areas of daily living, including:

Education Level
Employment Level
Income Level
Personal Living Skills
Kitchen Skills
Mobility Level
Reading/Writing Skills
Oral Communication Skills
Social Skills
Technology Level
Financial Management Skills
Recreation Skills
Organizational Skills
Independence Level

Each of these categories include a progressive scale of 10 activities, 1 being the lowest level of functionality and 10 being the highest level of functionality. Most of the categories are easily self-evaluated, though some will require one-on-one discussion with the test administrator. At the completion of the Functional Assessment Questionnaire, a functionality score, ranging between 14 and 140 is tabulated for each individual.

In order to maintain scientific integrity of the Functional Assessment Questionnaire, certain non-identifiable information will be collected on each human subject. This information includes:

Age
Sex
Visual Acuity (BCVA)
Peripheral Field
Diagnosed Eye Condition

Comparative statistical analysis will be performed with the Functional Assessment Questionnaire results and the widely used SF-36 (36-Item Short Form Health Survey Instrument) and NEI-VFQ-25 with Appendix (National Eye Institute/Visual Function Questionnaire-25) questionnaires. The goal will be to check which questionnaire is more sensitive and accurate in measuring functional level outcomes both prior to (low-functioning individuals) and after (high functioning individuals) vision rehabilitation program participation.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Approximately 30 legally blind individuals. Between 12-15 individuals will be categorized as poor or low-functioning, and the same number of subjects that are categorized as high-functioning.

The factors that will establish high-functioning abilities will be outward skills in adapting to vision loss, such as:

Employment in mainstream job market
Extensive vision rehabilitation
Inclusion into mainstream society
Success in real world
Demonstrated ability to live independently, shop, cook, clean, pay bills, and move around safely without assistance.

Criteria

Inclusion Criteria:

Between ages of 18 and 80.
Capacity to complete the informed consent process
Legally blind (best corrected visual acuity of 20/200 or greater, and/or vision field of 20 degrees or less).
Long-term or short-term blindness with no or minimal vision rehabilitation. (These will be considered low-functioning subjects). or
Legally blind with extensive vision rehabilitation, independent and self-sufficient. (These will be considered high-functioning subjects).

Exclusion Criteria:

Patients who have incapacitating physical and mental challenges other than vision loss.
Patients who are not legally blind.
Patients who have had some vision rehabilitation, thus falling in between a high-functioning and low-functioning category.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407901

Sponsors and Collaborators

George Washington University

Investigators

Principal Investigator:

Craig Geist, M.D., M.S.

George Washington University

More Information

Publications:

Lingebach D, Olszowy R, Zollman R and Geist CE. Functional Assessment Questionaire for Low Vision. Abstract. Envision Conference, Kansas City, September 22-23, 2006 Poster Session.

Responsible Party:	Dr. Craig Geist, M.D., M.S., The George Washington University University Medical Faculty Associates
ClinicalTrials.gov Identifier:	NCT00407901 History of Changes
Other Study ID Numbers:	GWUIRB#120526
Study First Received:	December 1, 2006
Last Updated:	January 16, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by George Washington University:

Visually Challenged
Legally Blind
Functional Assessment Questionnaire
Low Functioning
High Functioning

Additional relevant MeSH terms:

Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations

Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2012