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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
September 21, 2007
October 17, 2007
February 19, 2016
October 2007
December 2015   (Final data collection date for primary outcome measure)
Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: baseline, 3months, 6 months, 12 months, 24 months ]
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Complete list of historical versions of study NCT00545220 on ClinicalTrials.gov Archive Site
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Problem Solving Training and Low Vision Rehabilitation
Problem Solving Training and Low Vision Rehabilitation
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Low Vision
  • Behavioral: problem-solving training
  • Behavioral: sham intervention
  • Experimental: 1
    PST
    Intervention: Behavioral: problem-solving training
  • Sham Comparator: 2
    Attention Control
    Intervention: Behavioral: sham intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00545220
X060817006
5K23EY017327-02 ( U.S. NIH Grant/Contract )
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University of Alabama at Birmingham
University of Alabama at Birmingham
National Eye Institute (NEI)
Principal Investigator: Laura Dreer, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP