Functional Assessment Questionnaire for the Visually Challenged

NCT ID: NCT00407901

Last Updated: 2008-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-08-31

Brief Summary

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.

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.

Conditions

Blindness, Legal

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

A, B

A: High functioning visually challenged (legally blind) B: Low-functioning visually challenged (legally blind)

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

The George Washington University University Medical Faculty Associates

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

George Washington University

References

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.

Reference Type: RESULT

Other Identifiers

GWUIRB#120526

Identifier Type: -

Identifier Source: org_study_id