Problem Solving Training and Low Vision Rehabilitation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00545220
First received: September 21, 2007
Last updated: August 11, 2014
Last verified: June 2014

September 21, 2007
August 11, 2014
October 2007
December 2014   (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 ] [ Designated as safety issue: No ]
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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 Blind (Subject)
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.
 
Active, not recruiting
430
February 2015
December 2014   (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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00545220
X060817006, 5K23EY017327-02
Not Provided
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
June 2014

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