Problem Solving Training and Low Vision Rehabilitation

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT00545220

Collaborator

National Eye Institute (NEI) (NIH)

430

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Vision	Behavioral: problem-solving training Behavioral: sham intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

430 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Problem Solving Training and Low Vision Rehabilitation

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 PST	Behavioral: problem-solving training
Sham Comparator: 2 Attention Control	Behavioral: sham intervention

Arm

Intervention/Treatment

Experimental: 1

PST

Behavioral: problem-solving training

Sham Comparator: 2

Attention Control

Behavioral: sham intervention

Outcome Measures

Primary Outcome Measures

Center for Epidemiological Studies Depression Scale (CES-D) [baseline, 3months, 6 months, 12 months, 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham
National Eye Institute (NEI)

Investigators

Principal Investigator: Laura Dreer, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00545220

Other Study ID Numbers:

X060817006
5K23EY017327-02

First Posted:

Oct 17, 2007

Last Update Posted:

Feb 19, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Vision, Low

Study Results

No Results Posted as of Feb 19, 2016