Problem Solving Training and Low Vision Rehabilitation

Low Vision Clinical Trial

Official title:

Problem Solving Training and Low Vision Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545220
• Other study ID #: X060817006
• Secondary ID: 5K23EY017327-02
• Status: Completed
• Phase: N/A
• First received: September 21, 2007
• Last updated: February 17, 2016
• Start date: October 2007
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Vision
• Vision, Low

Intervention

Behavioral:
• problem-solving training

• sham intervention

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Center for Epidemiological Studies Depression Scale (CES-D)		baseline, 3months, 6 months, 12 months, 24 months	No