Diabetic RetinopathyNCT01364129
The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
A study testing Ophthalmic Telemedicine in people with Diabetic Retinopathy, run by Legacy Health System at 2 sites in United States.
Trial summary
This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Ophthalmic Telemedicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 567 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Jun 2012
- 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
- diabetic, at least 18 years old, patient at a participating health clinic
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yellowhawk Tribal Health Center
Pendleton, Oregon, 97801
Hunter Health Clinic
Wichita, Kansas, 67214
About this study
This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system from the perspective of the community clinic, the third-party payer, and the individual patient.
- Conditions
- Diabetic Retinopathy
- Being tested
- Ophthalmic Telemedicine
- Keywords
- Diabetes, Diabetic Retinopathy Screening, Ophthalmic Telemedicine, Comparative Effectiveness Research
- 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.
Ophthalmic TelemedicineProcedure or surgery
Participants receiving the intervention have digital images of their retina captured with a non-mydriatic camera. The images are then sent to Devers Eye Institute for review and report generation.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Participants in this group have digital images of their retina captured with a non-mydriatic camera and are encouraged to see an eye care provider yearly. Receives: Procedure: Ophthalmic Telemedicine |
| Traditional Surveillance | No intervention | Participants in this group are encouraged to see an eye care provider each year for a diabetic eye exam. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants that Receive Annual Eye Exam
This outcome measure will be used to determine (1) whether the telemedicine system increases the proportion of participants that receive an annual eye exam, and (2) what health belief factors are associated with adherence.
Measured: Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startAug 2006
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Oregon Health and Science University
- Responsible party
- Principal investigator, Steven L. Mansberger, Legacy Health System
- Investigators
- Steven L Mansberger, MD, MPH, Principal investigator, Legacy Health System, Devers Eye InstituteThomas M Becker, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364129
- Sponsor's protocol ID
- NPAIHB O5-P-O5
- Other IDs
- 1-U-48-DP-002673
- Status last verified
- Mar 2016
- First submitted
- 27 Apr 2011
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Park DW, Mansberger SL. Eye Disease in Patients with Diabetes Screened with Telemedicine. Telemed J E Health. 2017 Feb;23(2):113-118. doi: 10.1089/tmj.2016.0034. Epub 2016 Jun 21.
PubMed 27328169Mansberger SL, Sheppler C, Barker G, Gardiner SK, Demirel S, Wooten K, Becker TM. Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 May;133(5):518-25. doi: 10.1001/jamaophthalmol.2015.1.
PubMed 25741666
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01364129
- Acronym / sponsor ID
- NPAIHB O5-P-O5
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes, Diabetic Retinopathy Screening, Ophthalmic Telemedicine, Comparative Effectiveness Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Oregon Health and Science University
- Study start
- Aug 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Jun 2011 (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.
This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system from the perspective of the community clinic, the third-party payer, and the individual patient.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Procedure: Ophthalmic TelemedicineParticipants in this group have digital images of their retina captured with a non-mydriatic camera and are encouraged to see an eye care provider yearly. |
| Traditional Surveillance | No intervention | –Participants in this group are encouraged to see an eye care provider each year for a diabetic eye exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic, at least 18 years old, patient at a participating health clinic
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ophthalmic TelemedicineParticipants receiving the intervention have digital images of their retina captured with a non-mydriatic camera. The images are then sent to Devers Eye Institute for review and report generation. | Procedure or surgery | Telemedicine |
Primary outcome
Proportion of Participants that Receive Annual Eye Exam
Time frame: Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study)
This outcome measure will be used to determine (1) whether the telemedicine system increases the proportion of participants that receive an annual eye exam, and (2) what health belief factors are associated with adherence.
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 9 Mar 2016.
- Derived from this study: PubMed 27328169Park DW, Mansberger SL. Eye Disease in Patients with Diabetes Screened with Telemedicine. Telemed J E Health. 2017 Feb;23(2):113-118. doi: 10.1089/tmj.2016.0034. Epub 2016 Jun 21.
- Derived from this study: PubMed 25741666Mansberger SL, Sheppler C, Barker G, Gardiner SK, Demirel S, Wooten K, Becker TM. Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 May;133(5):518-25. doi: 10.1001/jamaophthalmol.2015.1.
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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.
Steven L Mansberger, MD, MPH principal investigator
Legacy Health System, Devers Eye Institute
Thomas M Becker, MD, PhD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmic Telemedicine in people with Diabetic Retinopathy, run by Legacy Health System at 2 sites 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 1 inclusion and 0 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of Participants that Receive Annual Eye Exam (time frame: Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study)). 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 NCT01364129, which also lists 2 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 9 Mar 2016.