Problem Solving Training and Low Vision Rehabilitation
Recruitment status was Recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 21, 2007 | ||||
| Last Updated Date | October 16, 2007 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00545220 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Problem Solving Training and Low Vision Rehabilitation | ||||
| Official Title ICMJE | Problem Solving Training and Low Vision Rehabilitation | ||||
| Brief 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
||||
| Condition ICMJE | Low Vision | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Estimated Completion Date | October 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00545220 | ||||
| Other Study ID Numbers ICMJE | X060817006, 5K23EY017327-02 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
| Collaborators ICMJE | National Eye Institute (NEI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Eye Institute (NEI) | ||||
| Verification Date | October 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||