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Diabetes Mellitus, Type 1Early Phase 1NCT00417924

Eye on Diabetes: A Multidisciplinary Patient Education Intervention

A Early Phase 1 study testing Patient education in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Nova Southeastern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Vision loss from diabetes is often preventable with timely detection and treatment. Patients with diabetes may not understand the importance of annual dilated eye examinations or recognize the benefits of early detection of diabetic eye disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patient education
How many people
90 participants
Where
1 siteUnited States
Study dates
Oct 2004to Oct 2005
Phase
Early Phase 1
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

  • Adult patients with Type I or Type II Diabetes
  • English speaking

Who cannot join

  • Visual acuity worse than 20/60

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sanford L. Ziff Health Center

    Fort Lauderdale, Florida, 33328

Other trials in United States

About this study

Official title: Eye Health and Vision Care for Patients With Diabetes: Comparing Usual Care to a Targeted Intervention in a Randomized Controlled Trial

Vision loss from diabetes is often preventable with timely detection and treatment. Patients with diabetes may not understand the importance of annual dilated eye examinations or recognize the benefits of early detection of diabetic eye disease. The proposed research project compares usual eye care to eye care emphasizing patient education for adult patients with diabetes.

Read the detailed description

Patients with diabetes may not understand the importance of annual dilated eye examinations or recognize the benefits of early detection of diabetic eye disease. The goal of this study is to compare the efficacy of usual care to an intervention emphasizing patient education targeted at a multicultural adult patient population with diabetes seeking eye care in an academic health center. The specific aims of this study are to evaluate patient knowledge of preventive health strategies for diabetes as they pertain to eye health and vision care, to assess patient satisfaction with eye and vision care, and to promote interdisciplinary collaboration in the care of patients with diabetes.

Ninety patients were randomized to two arms representing usual care and an intervention emphasizing patient education targeted at English-speaking adults with diabetes seeking eye care in an academic health center. The project was developed within the Health Professions Division at Nova Southeastern University.

Participation was comprised of a comprehensive eye health and vision examination, patient education, and completion of study instruments described below. A demographic survey documenting patient age, sex, physician-reported HbA1C, education, and birthplace was administered to all patients at baseline. Race and ethnicity were self reported using categories in current use by the National Eye Institute, National Institutes of Health (Bethesda, MD).

Patients assigned to the intervention were provided with a written report at the conclusion of the examination. The triplicate form included a report of eye examination findings with a copy designated for the medical record, the primary care physician, and the patient. The back side of the patient's copy included educational materials targeted at a layperson while the physician's copy included information directed at a primary health care provider.

Patients assigned to usual care received patient education at the discretion of the eye care provider. Following the initial examination, all medical records were reviewed with attention to communication with other health care providers, as well as other issues related to continuity and coordination of care. Patients assigned to usual care were mailed additional written educational materials at the conclusion of the study, after all study instruments had been completed.

Patients assigned to the intervention were invited to participate in a supplementary seminar that reinforced the educational message delivered at the time of the initial examination. A multidisciplinary (optometry, pharmacy, endocrinology) patient education curriculum incorporating materials from the National Eye Health Education Program (NEHEP) Diabetic Eye Disease Public Education Program, the "ABC's of diabetes", an interactive activity, and a question and answer session was developed for patients randomized to the intervention.

Being tested
Patient education
Keywords
Patient education, Patient satisfaction, Eye health
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient educationBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient knowledge (pre-test, post-test, and 3 month post-test)

  2. Patient satisfaction post-examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2007 (estimated)
  2. Study startOct 2004
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00417924
Sponsor's protocol ID
OPT06170409X
Status last verified
Dec 2006
First submitted
2 Jan 2007
Last updated
4 Jan 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Patient education in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Nova Southeastern University 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 2 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 4 Jan 2007. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Patient knowledge (pre-test, post-test, and 3 month post-test). The study lists 2 primary outcomes in all. 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 4 Jan 2007.

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