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VA Low Vision Intervention Trial (LOVIT)

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ClinicalTrials.gov Identifier: NCT00223756
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 8, 2016
Study Start Date  ICMJE November 2004
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
VA LV VFQ-48 Reading Domain Scores [ Time Frame: 4 months from baseline ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Primary outcomes measure change: in difficulty performing tasks in the reading domain as measured with the VA LV VFQ-48 from baseline to four months after randomization.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Secondary outcomes measure change: in difficulty performing tasks/all items on the VA LV VFQ-48, in self-report of depressive feelings with the Center for Epidemiological Studies Depression Scale (CES-D), in self-report of health assessment using the MOS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VA Low Vision Intervention Trial
Official Title  ICMJE VA Low Vision Intervention Trial
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 854,000 severely visually impaired veterans in the year 2005 and 890,000 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 $27,826 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 Veteran's 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 program).The .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 1/2 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 veteran's 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vision, Low
Intervention  ICMJE Other: Low Vision Intervention - Outpatient Training Program
Patients receive LV therapy as outpatients
Other Name: Therapy Group
Study Arms  ICMJE
  • Experimental: Arm 1
    interdisciplinary, outpatient blind rehabilitation
    Intervention: Other: Low Vision Intervention - Outpatient Training Program
  • No Intervention: Arm 2
    usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 13, 2005)
61
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Primary eye diagnosis (in better seeing eye) of either macular degeneration, macular dystrophy, macular hole or inflammatory disease of the macula
  2. Habitual visual acuity (in better seeing eye) better than 20/500 but less than 20/100

Exclusion Criteria:

  1. does not have a phone
  2. does not speak English
  3. has previously received low vision services as part of an inpatient blind rehabilitation program
  4. has participated in a low vision program that provided low vision devices to meet reading needs with low vision therapy administered by an occupational therapist or vision rehabilitation professional since most recent significant decrease in vision
  5. has English literacy less than 5th grade level
  6. has habitual visual acuity in better seeing eye of equal to or better than 20/100, less than or equal to 20/500
  7. fails Telephone Interview of Cognitive Status (TICS) screening (score of 30 or lower)
  8. has history of stroke with aphasia
  9. has other health condition that would preclude follow-up (e.g. significant malignancy or life-threatening disease)
  10. is unable or unwilling to attend clinic visits required for the study
  11. has severe hearing impairment that interferes with participation in telephone questionnaires
  12. reports significant loss of vision since last eye exam
  13. has vitreous hemorrhage, serous or hemorrhagic detachment of the macula, clinically significant macular edema or cystoid macular edema that is likely to result in further loss or improvement in vision after treatment in better seeing eye
  14. plans cataract extraction in the next 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223756
Other Study ID Numbers  ICMJE C3457-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joan Stelmack, OD MPH Edward Hines Jr. VA Hospital
PRS Account VA Office of Research and Development
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP