Clinical trial NCT00407901: Functional Assessment Questionnaire for the Visually Challenged
Official title: Functional Assessment Questionnaire for the Visually Challenged: Proposed Model to Quantitatively Measure the Functional Level of Individuals Who Are Legally Blind
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blindness, Legal
Keywords: Visually Challenged
Legally Blind
Functional Assessment Questionnaire
Low Functioning
High Functioning
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2006-12-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: George Washington University
name: Craig Geist, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.