Functional Assessment Questionnaire for the Visually Challenged

This study has been completed.
Sponsor:
Information provided by:
George Washington University
ClinicalTrials.gov Identifier:
NCT00407901
First received: December 1, 2006
Last updated: January 16, 2008
Last verified: January 2008
  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:

  1. Education Level
  2. Employment Level
  3. Income Level
  4. Personal Living Skills
  5. Kitchen Skills
  6. Mobility Level
  7. Reading/Writing Skills
  8. Oral Communication Skills
  9. Social Skills
  10. Technology Level
  11. Financial Management Skills
  12. Recreation Skills
  13. Organizational Skills
  14. 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:

  1. Age
  2. Sex
  3. Visual Acuity (BCVA)
  4. Peripheral Field
  5. 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:

  1. Employment in mainstream job market
  2. Extensive vision rehabilitation
  3. Inclusion into mainstream society
  4. Success in real world
  5. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014