Blindness, LegalNCT00407901
Functional Assessment Questionnaire for the Visually Challenged
An observational study of Blindness, Legal, run by George Washington University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blindness, Legal
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Aug 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Functional Assessment Questionnaire for the Visually Challenged: Proposed Model to Quantitatively Measure the Functional Level of Individuals Who Are Legally Blind
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.
Read the 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.
- Conditions
- Blindness, Legal
- Keywords
- Visually Challenged, Legally Blind, Functional Assessment Questionnaire, Low Functioning, High Functioning
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A, B | A: High functioning visually challenged (legally blind) B: Low-functioning visually challenged (legally blind) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blindness, LegalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Investigators
- Craig Geist, M.D., M.S., Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407901
- Sponsor's protocol ID
- GWUIRB#120526
- Status last verified
- Jan 2008
- First submitted
- 1 Dec 2006
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment Questionnaire for the Visually Challenged: Proposed Model to Quantitatively Measure the Functional Level of Individuals Who Are Legally Blind
- ClinicalTrials.gov ID
- NCT00407901
- Acronym / sponsor ID
- GWUIRB#120526
- Conditions
- Blindness, Legal
- Keywords
- Visually Challenged, Legally Blind, Functional Assessment Questionnaire, Low Functioning, High Functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, B | – | –A: High functioning visually challenged (legally blind) B: Low-functioning visually challenged (legally blind) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2008.
- Results publicationLingebach 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Geist, M.D., M.S. principal investigator
George Washington University
Questions about this trial
What is this clinical trial studying?
An observational study of Blindness, Legal, run by George Washington University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2008.