Diabetic RetinopathyNCT00799695
Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population
A study testing phone call contact in people with Diabetic Retinopathy, run by Henry Ford Health System at 1 site in United States.
Trial summary
Diabetic retinopathy is the major cause of blindness in working age Americans, and screening for it is cost-effective. There are a quarter of a million people in Southeast Michigan with diabetes and pre-diabetes. 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?
- phone call contact
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 561 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2008
- 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
- were Henry Ford Health System patients,
- diabetic
- using the BCBSM payer plan
Who cannot join
- retina examination in prior year
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic retinopathy is the major cause of blindness in working age Americans, and screening for it is cost-effective. There are a quarter of a million people in Southeast Michigan with diabetes and pre-diabetes.
Only half of patients with diabetes are screened regularly for diabetic retinopathy, and this proportion has been difficult to increase despite various interventions. Previous research focused on HMO patient groups because preventative care was thought to decrease plan costs. In addition, it was administratively feasible to track patient-doctor interactions.
Read more
This project builds on published research and institutional experience to determine an effective method for increasing the screening rate, in a mobile, non-HMO population. It uses administrative methods and information technology infrastructures, such as large scale electronic medical records and patient demographic databases, to identify existing patients requiring examinations.
Patients were telephoned by a trained service representative who offered and scheduled firm examination appointment times.
Hypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in non-HMO patient groups by directly contacting patients and scheduling firm appointment times.
- Conditions
- Diabetic Retinopathy
- Being tested
- phone call contact
- Keywords
- diabetic retinopathy, screening, annual
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone call contactBehavioural
A sample of subjects who had not completed their annual diabetic screening exams were contacted by phone and offered appointments for eye exams
What is being measured
The primary outcome is the main question the study is designed to answer.
a change in the proportion of diabetic patients who acted as a result of the phone contact, and obtained a retina eye exam.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Investigators
- Robert M Levine,, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799695
- Sponsor's protocol ID
- F10030
- Other IDs
- F10030, 13.13PIRAP
- Status last verified
- Nov 2008
- First submitted
- 26 Nov 2008
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population
- ClinicalTrials.gov ID
- NCT00799695
- Acronym / sponsor ID
- F10030
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, screening, annual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 1 Dec 2008 (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.
Diabetic retinopathy is the major cause of blindness in working age Americans, and screening for it is cost-effective. There are a quarter of a million people in Southeast Michigan with diabetes and pre-diabetes.
Only half of patients with diabetes are screened regularly for diabetic retinopathy, and this proportion has been difficult to increase despite various interventions. Previous research focused on HMO patient groups because preventative care was thought to decrease plan costs. In addition, it was administratively feasible to track patient-doctor interactions.
This project builds on published research and institutional experience to determine an effective method for increasing the screening rate, in a mobile, non-HMO population. It uses administrative methods and information technology infrastructures, such as large scale electronic medical records and patient demographic databases, to identify existing patients requiring examinations.
Patients were telephoned by a trained service representative who offered and scheduled firm examination appointment times.
Hypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in non-HMO patient groups by directly contacting patients and scheduling firm appointment times.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- were Henry Ford Health System patients,
- diabetic
- using the BCBSM payer plan
Key exclusion criteria (1 listed)
- retina examination in prior year
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 |
|---|---|---|
| phone call contactA sample of subjects who had not completed their annual diabetic screening exams were contacted by phone and offered appointments for eye exams | Behavioural | – |
Primary outcome
a change in the proportion of diabetic patients who acted as a result of the phone contact, and obtained a retina eye exam.
Time frame: 3 months
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 1 Dec 2008.
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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.
Robert M Levine,, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phone call contact in people with Diabetic Retinopathy, run by Henry Ford Health System 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 3 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 1 Dec 2008. 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?
a change in the proportion of diabetic patients who acted as a result of the phone contact, and obtained a retina eye exam. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2008.