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NCT01179555 · ClinicalTrials.gov registry record · NA
Confronting Unequal Eye Care in Pennsylvania
A NA study, sponsored by Wills Eye.
- Completed
- Registry status
- NA
- Development phase
- 206
- Enrollment target
NCT01179555: Completed NA study, sponsored by Wills Eye.
NCT01179555 is a NA study that has completed, run by Wills Eye. The registered enrollment target is 206 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01179555, a NA study, has completed, sponsored by Wills Eye.
- COMPLETED
- Registry status
- NA
- Development phase
- 206 participants
- Enrollment target
Study Summary
Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe vision impairment and even blindness. African Americans are more likely to have vision loss from diabetic retinopathy due to a variety of factors, including cultural barriers to care. The investigators aim to increase the rates of eye exams in diabetic African American adults by providing culturally relevant home-based interventions. These interventions will increase the knowledge about diabetes and the eyes and the awareness of ocular risks due to diabetes. 206 African American adults, over the age of 65, with diabetes will be recruited from primary care clinics at Thomas Jefferson and Temple University. Eligible patients who consent to participate will have baseline information taken about medical and ocular history, understanding of diabetes and a hemoglobin A1C level obtained. The subjects will then be randomized to one of two treatment conditions: Behavioral Activation or Supportive Therapy, each of which will be delivered over 4 sessions. Behavioral Activation will consist of educational materials, referral assistance for eye clinics, and addressing patient specific barriers to care. Supportive Therapy will consist of supportive but non-directional interaction with the patient exploring the impact of aging and diabetes on the patient's life. The investigators hypothesize that more patients who receive Behavioral Activation will have a dilated fundus exam (the primary outcome variable), understand the risks of diabetic complications and feel less depression then subjects who receive Supportive Therapy.
Primary Outcome
At the 6-month follow-up assessment, patients will be asked if they got a dilated fundus exam since the baseline assessment. If a DFE is self-reported, it will be confirmed by ophthalmology chart review
Interventions
- BEHAVIORAL Supportive Therapy
- BEHAVIORAL Behavioral Activation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-05 |
| Phase | NA |
What the finished NCT01179555 record still lists
NCT01179555 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Supportive Therapy is the first listed.
NCT01179555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01179555 about?
NCT01179555 is a clinical study titled "Confronting Unequal Eye Care in Pennsylvania". Pt. 1 Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe vision impairment and even blindness. African Americans are more likely to have vision loss from diabetic retinopathy due to a variety of factors, including cultural barriers to care. The investigators ...
What is the current status of trial NCT01179555?
This trial is currently completed. It is a NA study. The enrollment target is 206 participants. The study started on 2010-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01179555?
The interventions under investigation include: Supportive Therapy (BEHAVIORAL), Behavioral Activation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01179555?
This trial is sponsored by Wills Eye, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01179555's enrollment target sits among peer trials
206 499th of 2000 higher than 1,502 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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