Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 3, 2012 | ||||
| Last Updated Date | December 4, 2012 | ||||
| Start Date ICMJE | October 2012 | ||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
All Aims: DFE follow-up adherence rate [ Time Frame: 2 years ] [ Designated as safety issue: No ] In Aim 1 and Aim 2 specifically the influence patients' ethnicity and severity of diabetic retinopathy will be examined with the rate of dilated fundus examine (DFE) follow-up adherence. In Aim 3, the rate of DFE follow-up adherence will be examined for both patients in the contract and the no contract group. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01744132 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Aim 3: Rates of ocular disease [ Time Frame: 2 years ] [ Designated as safety issue: No ] In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected. |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The goal of this project is to implement a Collaborative Translational Research Center (TRC) Network Study which aims to assure optimal two-way communication between ophthalmologists and their patients' primary care physicians (PCP). The Collaborative TRC Network Study will have 2 objectives:
By enhancing communication and strengthening the clinical information exchanged between PCPs and eye care professionals, this Collaborative TRC Network study will help to overcome barriers to obtaining ongoing DFEs and reduce disparities in vision care utilization. |
||||
| Detailed Description | Since its inception in October 2010 Collaborative Network Research Study at the Wills Eye Institute has aimed:
|
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Behavioral: Aim 3: Contract | ||||
| 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 | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Aim 1:
Exclusion Criteria for Aim 1: 1) Pregnant women Inclusion Criteria for Aim 2 and 3:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01744132 | ||||
| Other Study ID Numbers ICMJE | U58DP002655 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Julia Haller, Wills Eye | ||||
| Study Sponsor ICMJE | Wills Eye | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Wills Eye | ||||
| Verification Date | December 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||