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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
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Vision

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 21, 2007
Last Updated
February 17, 2016
Sponsor
University of Alabama at Birmingham
Collaborators
National Eye Institute (NEI)
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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

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Problem Solving Training and Low Vision Rehabilitation

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