Problem Solving Training and Low Vision Rehabilitation

NCT ID: NCT00545220

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Vision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

PST

Group Type EXPERIMENTAL

problem-solving training

Intervention Type BEHAVIORAL

2

Attention Control

Group Type SHAM_COMPARATOR

sham intervention

Intervention Type BEHAVIORAL

Interventions

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problem-solving training

Intervention Type BEHAVIORAL

sham intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Dreer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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5K23EY017327-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

X060817006

Identifier Type: -

Identifier Source: org_study_id

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