Problem Solving Training and Low Vision Rehabilitation
Primary Purpose
Low Vision
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
problem-solving training
sham intervention
Sponsored by
About this trial
This is an interventional treatment trial for Low Vision
Eligibility Criteria
Inclusion Criteria:
- +19 yrs of age
- Underwent a low vision rehabilitation initial eye exam
- No more than 2 errors on cognitive on cognitive screening measure (SPBS)
- Must have access to telephone
- No significant hearing problems
- No significant communication problems
- Speaks fluent English
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
PST
Attention Control
Outcomes
Primary Outcome Measures
Center for Epidemiological Studies Depression Scale (CES-D)
Secondary Outcome Measures
Full Information
NCT ID
NCT00545220
First Posted
September 21, 2007
Last Updated
February 17, 2016
Sponsor
University of Alabama at Birmingham
Collaborators
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00545220
Brief Title
Problem Solving Training and Low Vision Rehabilitation
Official Title
Problem Solving Training and Low Vision Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
Vision loss can result in feelings of frustration, helplessness, anxiety, depression, and anger, which compromise a person's activities of everyday living. While emotional distress may resolve in some persons without intervention, unmanaged and persistent distress places the person at risk for continued decrements in health status and the potential development of more severe conditions (i.e., depression, poor health outcomes). Persons with low vision will be recruited and randomly assigned to either an innovative, problem-solving training (PST) intervention group designed specifically for persons with low vision or a sham intervention/control group. Primary and secondary outcomes will be assessed at baseline prior to intervention and at 3 month follow-up, 7 month follow-up, 12 month follow-up, and 24 month follow-up by a research interviewer masked to participants' randomization. This project will: (1) demonstrate how specified physical and emotional outcomes of persons with low vision change across time, (2) evaluate the effectiveness of a PST intervention that will be delivered to persons with low vision; and (3) identify persons with low vision who are at risk for adverse emotional and health outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PST
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Attention Control
Intervention Type
Behavioral
Intervention Name(s)
problem-solving training
Intervention Type
Behavioral
Intervention Name(s)
sham intervention
Primary Outcome Measure Information:
Title
Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame
baseline, 3months, 6 months, 12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
+19 yrs of age
Underwent a low vision rehabilitation initial eye exam
No more than 2 errors on cognitive on cognitive screening measure (SPBS)
Must have access to telephone
No significant hearing problems
No significant communication problems
Speaks fluent English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Dreer, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Problem Solving Training and Low Vision Rehabilitation
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