Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223756
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2005-09-13
Brief Title:
VA Low Vision Intervention Trial
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
VA Low Vision Intervention Trial
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOVIT
Brief Summary:
The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with central vision loss The hypothesis is that veterans in the treatment group will self-report less difficulty performing daily activities than veterans in the control group who are on a waiting list for VA low vision or blind rehabilitation programs
Detailed Description:
Abstract Research Question
Estimates are that there will be 854000 severely visually impaired veterans in the year 2005 and 890000 in the year 2010 Statistics based upon the 2000 census suggest that it will be well into the next decade before the number of severely visually impaired veterans begins to decrease Waiting time for admission to VA blind rehabilitation centers BRCs is often a year or more Low vision services are an important aspect of blind rehabilitation as 85 of veterans admitted to BRCs have useful remaining vision In the private sector low vision services are provided in outpatient settings Yet legally blind veterans are still encouraged if not required to attend regional inpatient programs to obtain therapy with low vision devices because a reimbursement model is not available for outpatient blind rehabilitation and few low vision outpatient clinics have rehabilitation professionals to provide this training The VA system needs alternative service delivery options for veterans who are unable to participate in inpatient rehabilitation Outpatient low vision programs should provide continuity of care with the regional BRC programs and insure local access to low vision care that is high quality timely and cost-effective Currently the VERA Reimbursement Model allocates 27826 per blind rehabilitation admission Outpatient low vision programs have the potential to substitute for inpatient low vision services and more costly inpatient rehabilitation programs may not be necessary for higher functioning veterans The purpose of the proposed research is to measure the effectiveness of a low vision outpatient program for legally blind veterans with central vision loss from macular diseases that could be provided at local VA facilities
Specific Objectives are to
1 Compare the mean change in self-report of difficulty performing daily activities measured with the Veterans Affairs Low Vision Visual Function Questionnaire - 48 VA LV VFQ-48 reading domain scores from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient program or usual care waiting list control group
2 Determine if the mean change in VA LV VFQ-48 composite and reading domain scores from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient program or usual care waiting list control group can be predicted by baseline measures of visual impairment functional status and life state or explained by measures of functional status after rehabilitation
3 Perform an economic evaluation of costs and cost-effectiveness of the low vision outpatient program
4 Compare the mean change in VA LV VFQ-48 scores from the clinical trial from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient program to historical data on the mean change in VA LV VFQ-48 scores from the Hines BRC program
Hypothesis Compared to the usual care waiting list control group veterans in the treatment group will self-report a reduction of 78 logits or more in difficulty performing daily living activities measured by the VA LV VFQ-48 reading domain scores from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient programThe 78 logit change is clinically significant as this improvement corresponds to the change in visual ability that would accompany a 6-line improvement on an EDTRS visual acuity chart
Significance The NIH includes visual impairment chronic visual deficiencies that impair everyday function that are not correctable by ordinary glasses among the 10 most prevalent causes of disability in America Persons confronted with vision loss often feel limited and frustrated performing everyday activities such as reading traveling from place to place and recognizing objects or people As a result they may experience loss of self esteem social isolation difficulty working and reduced independence The low vision team evaluates the level of remaining vision prescribes special lenses or devices and techniques for using remaining vision more effectively Low vision rehabilitation restores independence by enabling persons with vision loss to perform daily living tasks independently at home at work or within the community
Research Design the proposed study is a randomized clinical trial conducted at two sites Subjects are 122 legally blind veterans from Hines Hospital and Heffner VAMC Veterans will be randomized to treatment from a new low vision outpatient program or a usual care waiting list control group Following a low vision examination veterans in the treatment group will receive 5 2-2 12 hour therapy sessions at the local VA sites and one home visit to evaluate the home environment and set up prescribed devices The primary outcome measure is change in reading domain scores on the VA LV VFQ-48 a telephone questionnaire where subjects self-report their difficulty performing daily living activities in the community Other measures include instructors rating of veterans visual skills and use of low vision devices after rehabilitation visual skills for reading PEPPER VSRT health status SF-36 and symptoms of depression CES-D Outcomes will be compared with T tests Multiple linear regression models will be used to identify predictors and explain outcomes Costs and cost effectiveness of outpatient treatment compared to treatment in an inpatient BRC will be evaluated
Estimates are that there will be 854000 severely visually impaired veterans in the year 2005 and 890000 in the year 2010 Statistics based upon the 2000 census suggest that it will be well into the next decade before the number of severely visually impaired veterans begins to decrease Waiting time for admission to VA blind rehabilitation centers BRCs is often a year or more Low vision services are an important aspect of blind rehabilitation as 85 of veterans admitted to BRCs have useful remaining vision In the private sector low vision services are provided in outpatient settings Yet legally blind veterans are still encouraged if not required to attend regional inpatient programs to obtain therapy with low vision devices because a reimbursement model is not available for outpatient blind rehabilitation and few low vision outpatient clinics have rehabilitation professionals to provide this training The VA system needs alternative service delivery options for veterans who are unable to participate in inpatient rehabilitation Outpatient low vision programs should provide continuity of care with the regional BRC programs and insure local access to low vision care that is high quality timely and cost-effective Currently the VERA Reimbursement Model allocates 27826 per blind rehabilitation admission Outpatient low vision programs have the potential to substitute for inpatient low vision services and more costly inpatient rehabilitation programs may not be necessary for higher functioning veterans The purpose of the proposed research is to measure the effectiveness of a low vision outpatient program for legally blind veterans with central vision loss from macular diseases that could be provided at local VA facilities
Specific Objectives are to
1 Compare the mean change in self-report of difficulty performing daily activities measured with the Veterans Affairs Low Vision Visual Function Questionnaire - 48 VA LV VFQ-48 reading domain scores from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient program or usual care waiting list control group
2 Determine if the mean change in VA LV VFQ-48 composite and reading domain scores from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient program or usual care waiting list control group can be predicted by baseline measures of visual impairment functional status and life state or explained by measures of functional status after rehabilitation
3 Perform an economic evaluation of costs and cost-effectiveness of the low vision outpatient program
4 Compare the mean change in VA LV VFQ-48 scores from the clinical trial from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient program to historical data on the mean change in VA LV VFQ-48 scores from the Hines BRC program
Hypothesis Compared to the usual care waiting list control group veterans in the treatment group will self-report a reduction of 78 logits or more in difficulty performing daily living activities measured by the VA LV VFQ-48 reading domain scores from baseline to 4 months after randomization two months after veterans participate in a low vision outpatient programThe 78 logit change is clinically significant as this improvement corresponds to the change in visual ability that would accompany a 6-line improvement on an EDTRS visual acuity chart
Significance The NIH includes visual impairment chronic visual deficiencies that impair everyday function that are not correctable by ordinary glasses among the 10 most prevalent causes of disability in America Persons confronted with vision loss often feel limited and frustrated performing everyday activities such as reading traveling from place to place and recognizing objects or people As a result they may experience loss of self esteem social isolation difficulty working and reduced independence The low vision team evaluates the level of remaining vision prescribes special lenses or devices and techniques for using remaining vision more effectively Low vision rehabilitation restores independence by enabling persons with vision loss to perform daily living tasks independently at home at work or within the community
Research Design the proposed study is a randomized clinical trial conducted at two sites Subjects are 122 legally blind veterans from Hines Hospital and Heffner VAMC Veterans will be randomized to treatment from a new low vision outpatient program or a usual care waiting list control group Following a low vision examination veterans in the treatment group will receive 5 2-2 12 hour therapy sessions at the local VA sites and one home visit to evaluate the home environment and set up prescribed devices The primary outcome measure is change in reading domain scores on the VA LV VFQ-48 a telephone questionnaire where subjects self-report their difficulty performing daily living activities in the community Other measures include instructors rating of veterans visual skills and use of low vision devices after rehabilitation visual skills for reading PEPPER VSRT health status SF-36 and symptoms of depression CES-D Outcomes will be compared with T tests Multiple linear regression models will be used to identify predictors and explain outcomes Costs and cost effectiveness of outpatient treatment compared to treatment in an inpatient BRC will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None