Diabetic RetinopathyNCT01744132
Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes
A study testing Aim 3: Contract in people with Diabetic Retinopathy and Diabetes Mellitus, run by Wills Eye at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetes Mellitus
- What is being tested?
- Aim 3: Contract
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Type 2 diabetes mellitus
- Had a dilated fundus exam (DFE) within the past four years (2007-2010).
- Age ≥ 18 years
- Type 2 diabetes mellitus
- Access to a telephone
Who cannot join
- 1) Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Pharmacy
Philadelphia, Pennsylvania, 19107
About this study
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:
- To design and develop common research protocols to develop a 4-year retrospective database (2007-2010) that compiles electronic billing and medical chart information that can be used to study individual-level, clinical-level and system-level factors that impact access to and quality of vision care;
- To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary measureable quality indicator, and its relationship to the patients' demographics, ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP) communication.
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.
Read the detailed description
Since its inception in October 2010 Collaborative Network Research Study at the Wills Eye Institute has aimed:
- to establish a retrospective analysis of existing ophthalmic data sets to assess and evaluate system-level and individual-level factors that impact access to and quality of vision care in patients with diabetes;
- to implement telephone-based and educational interventions to improve DFE follow-up adherence in African Americans with diabetes utilizing a prospective, cluster-based, randomized cohort design;
- to determine the feasibility and effectiveness of using a non-invasive, non-mydriatic fundus camera (Nidek) in a community-based pharmacy setting to screen and detect diabetic retinopathy and other ocular diseases among individuals with diabetes.
- Conditions
- Diabetic Retinopathy, Diabetes Mellitus
- Being tested
- Aim 3: Contract
- Keywords
- eye care utilization, ophthalmology, educational intervention, public health screening
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim 3: ContractBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Aim 3: Contract | Experimental | Half of patients screened in the pharmacy are selected to a contract group, which encourages patients to review the results of the screen, share the results with their PCP, and schedule and attend a follow-up appointment with an ophthalmologist if the results are abnormal. Receives: Behavioral: Aim 3: Contract |
| Aim 3: Control | No intervention | No contract is signed for half of the patients screened in Aim 3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Aims: DFE follow-up adherence rate
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.
Measured: 2 years
Secondary outcomes (1)
Aim 3: Rates of ocular disease
In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Alabama at Birmingham, University of Miami, Johns Hopkins University
- Responsible party
- Principal investigator, Julia Haller, Wills Eye
- Investigators
- Julia Haller, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744132
- Sponsor's protocol ID
- U58DP002655
- Status last verified
- Nov 2016
- First submitted
- 3 Dec 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Keenum Z, McGwin G Jr, Witherspoon CD, Haller JA, Clark ME, Owsley C. Patients' Adherence to Recommended Follow-up Eye Care After Diabetic Retinopathy Screening in a Publicly Funded County Clinic and Factors Associated With Follow-up Eye Care Use. JAMA Ophthalmol. 2016 Nov 1;134(11):1221-1228. doi: 10.1001/jamaophthalmol.2016.3081.
PubMed 27632231Murchison AP, Friedman DS, Gower EW, Haller JA, Lam BL, Lee DJ, McGwin G Jr, Owsley C, Saaddine J, Insight Study Group. A Multi-Center Diabetes Eye Screening Study in Community Settings: Study Design and Methodology. Ophthalmic Epidemiol. 2016;23(2):109-15. doi: 10.3109/09286586.2015.1099682. Epub 2016 Mar 7.
PubMed 26949832Callinan CE, Kenney B, Hark LA, Murchison AP, Dai Y, Leiby BE, Mayro EL, Bilson J, Haller JA. Improving Follow-Up Adherence in a Primary Eye Care Setting. Am J Med Qual. 2017 Jan/Feb;32(1):73-79. doi: 10.1177/1062860615616860. Epub 2016 Jul 10.
PubMed 26656245Aleo CL, Murchison AP, Dai Y, Hark LA, Mayro EL, Collymore B, Haller JA. Improving eye care follow-up adherence in diabetic patients with ocular abnormalities: the effectiveness of patient contracts in a free, pharmacy-based eye screening. Public Health. 2015 Jul;129(7):996-9. doi: 10.1016/j.puhe.2015.05.012. Epub 2015 Jun 25.
PubMed 26119987Storey PP, Murchison AP, Pizzi LT, Hark LA, Dai Y, Leiby BE, Haller JA. IMPACT OF PHYSICIAN COMMUNICATION ON DIABETIC EYE EXAMINATION ADHERENCE: Results From a Retrospective Cohort Analysis. Retina. 2016 Jan;36(1):20-7. doi: 10.1097/IAE.0000000000000652.
PubMed 26098386
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes
- ClinicalTrials.gov ID
- NCT01744132
- Acronym / sponsor ID
- U58DP002655
- Conditions
- Diabetic Retinopathy, Diabetes Mellitus
- Keywords
- eye care utilization, ophthalmology, educational intervention, public health screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Alabama at Birmingham, University of Miami, Johns Hopkins University
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To design and develop common research protocols to develop a 4-year retrospective database (2007-2010) that compiles electronic billing and medical chart information that can be used to study individual-level, clinical-level and system-level factors that impact access to and quality of vision care;
- To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary measureable quality indicator, and its relationship to the patients' demographics, ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP) communication.
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:
- to establish a retrospective analysis of existing ophthalmic data sets to assess and evaluate system-level and individual-level factors that impact access to and quality of vision care in patients with diabetes;
- to implement telephone-based and educational interventions to improve DFE follow-up adherence in African Americans with diabetes utilizing a prospective, cluster-based, randomized cohort design;
- to determine the feasibility and effectiveness of using a non-invasive, non-mydriatic fundus camera (Nidek) in a community-based pharmacy setting to screen and detect diabetic retinopathy and other ocular diseases among individuals with diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 3: Contract | Experimental | Behavioral: Aim 3: ContractHalf of patients screened in the pharmacy are selected to a contract group, which encourages patients to review the results of the screen, share the results with their PCP, and schedule and attend a follow-up appointment with an ophthalmologist if the results are abnormal. |
| Aim 3: Control | No intervention | –No contract is signed for half of the patients screened in Aim 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Type 2 diabetes mellitus
- Had a dilated fundus exam (DFE) within the past four years (2007-2010).
- Age ≥ 18 years
- Type 2 diabetes mellitus
Key exclusion criteria (1 listed)
- 1) Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aim 3: Contract | Behavioural | Aim 3: Contract |
Primary outcome
All Aims: DFE follow-up adherence rate
Time frame: 2 years
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.
1 secondary outcome
Aim 3: Rates of ocular disease
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 27632231Keenum Z, McGwin G Jr, Witherspoon CD, Haller JA, Clark ME, Owsley C. Patients' Adherence to Recommended Follow-up Eye Care After Diabetic Retinopathy Screening in a Publicly Funded County Clinic and Factors Associated With Follow-up Eye Care Use. JAMA Ophthalmol. 2016 Nov 1;134(11):1221-1228. doi: 10.1001/jamaophthalmol.2016.3081.
- Background: PubMed 26949832Murchison AP, Friedman DS, Gower EW, Haller JA, Lam BL, Lee DJ, McGwin G Jr, Owsley C, Saaddine J, Insight Study Group. A Multi-Center Diabetes Eye Screening Study in Community Settings: Study Design and Methodology. Ophthalmic Epidemiol. 2016;23(2):109-15. doi: 10.3109/09286586.2015.1099682. Epub 2016 Mar 7.
- Background: PubMed 26656245Callinan CE, Kenney B, Hark LA, Murchison AP, Dai Y, Leiby BE, Mayro EL, Bilson J, Haller JA. Improving Follow-Up Adherence in a Primary Eye Care Setting. Am J Med Qual. 2017 Jan/Feb;32(1):73-79. doi: 10.1177/1062860615616860. Epub 2016 Jul 10.
- Background: PubMed 26119987Aleo CL, Murchison AP, Dai Y, Hark LA, Mayro EL, Collymore B, Haller JA. Improving eye care follow-up adherence in diabetic patients with ocular abnormalities: the effectiveness of patient contracts in a free, pharmacy-based eye screening. Public Health. 2015 Jul;129(7):996-9. doi: 10.1016/j.puhe.2015.05.012. Epub 2015 Jun 25.
- Background: PubMed 26098386Storey PP, Murchison AP, Pizzi LT, Hark LA, Dai Y, Leiby BE, Haller JA. IMPACT OF PHYSICIAN COMMUNICATION ON DIABETIC EYE EXAMINATION ADHERENCE: Results From a Retrospective Cohort Analysis. Retina. 2016 Jan;36(1):20-7. doi: 10.1097/IAE.0000000000000652.
- Individual participant dataSharing planned: No
Related trials for Diabetic Retinopathy
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Haller principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aim 3: Contract in people with Diabetic Retinopathy and Diabetes Mellitus, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Aims: DFE follow-up adherence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01744132, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.