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NCT Number: NCT00407901

Functional Assessment Questionnaire for the Visually Challenged

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

Functional Assessment Questionnaire for the Visually Challenged: Proposed Model to Quantitatively Measure the Functional Level of Individuals Who Are Legally Blind

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Dec 5, 2006
Registry last updated
Jan 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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