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Problem Solving Training and Low Vision Rehabilitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545220
First Posted: October 17, 2007
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
University of Alabama at Birmingham
  Purpose
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 Intervention
Low Vision Behavioral: problem-solving training Behavioral: sham intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Problem Solving Training and Low Vision Rehabilitation

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: baseline, 3months, 6 months, 12 months, 24 months ]

Enrollment: 430
Study Start Date: October 2007
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PST
Behavioral: problem-solving training
Sham Comparator: 2
Attention Control
Behavioral: sham intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545220


Locations
United States, Alabama
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
  More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00545220     History of Changes
Other Study ID Numbers: X060817006
5K23EY017327-02 ( U.S. NIH Grant/Contract )
First Submitted: September 21, 2007
First Posted: October 17, 2007
Last Update Posted: February 19, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms