Problem Solving Training and Low Vision Rehabilitation

NCT00545220 | Completed

• 2 other identifiers: X0608170065K23EY017327-02
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Vision

Outcome Measures

Primary Outcomes (1)

• Center for Epidemiological Studies Depression Scale (CES-D)

  baseline, 3months, 6 months, 12 months, 24 months

Study Arms (2)

1

EXPERIMENTAL

PST

Behavioral: problem-solving training

2

SHAM COMPARATOR

Attention Control

Behavioral: sham intervention

Interventions

problem-solving training BEHAVIORAL

1

sham intervention BEHAVIORAL

2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• +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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Dreer, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

US (1)