- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983917
Mobile Application to Enhance Diabetic Care
Clinical Trial of Mobile Application to Enhance Diabetic Health Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This community-based study will involve the participation of healthcare professionals and physicians who are already treating the patient. Support and adequate training of the mobile application and the research protocol will be provided by the Study Coordinator.
The patient/family caregiver be asked to check their vision at home via their mobile application at regularly scheduled intervals as determined by their ophthalmologist. Patients will be expected to review postings of their visual acuity and office visits at a minimum of once a month intervals.
A staff member from the physician's office will post pertinent data from each office visit using a template. The ophthalmology template will include visual acuity, intraocular pressure, treatments given (if any), and uploaded retinal images. The non-ophthalmology physicians will post their office visit data in a free-form text box. Data entry can be performed by office staff and does not have to be done by a physician. Physicians will have access to view visual acuity records and physician postings from their own patients.
The research coordinator will collect health psychology data by administering validated health psychology questionnaires to assess patient depression, knowledge regarding diabetes and complications of diabetes, motivation to carry out diabetes care, reaction to increased knowledge of specific tests for diabetes and diabetic complications, and quality of life at 4-month intervals throughout the Clinical Trial.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Jules Stein Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with diabetes mellitus and receiving care from either Jules Stein Eye Institute or the Gonda Diabetes Center at UCLA.
- Between 14 and 75 years if age at the time of enrollment.
- Internet access with Apple i-Phone, Apple i-Pad, and/or Apple i-Pod Touch on a weekly basis.
- English language and Internet capability for data entry, monitoring, and comprehension of reports.
- Able to attend Standard of Care visits for 1 to 3 years.
- Able to understand and willing to sign the informed consent perform and comply with all study procedures
Exclusion Criteria:
- Any social, mental or physical condition that impairs ability to give consent, maintain Internet access or attend physician visits.
- Prior or concurrent eye or vision condition that would interfere with participation in or interpretation of the study.
- Prior or concurrent disease or medical condition that is likely to compromise interpretation of the study.
3. Inability or unwillingness of the patient's diabetes medical care or ophthalmology vision care team to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Use of the Diabetes Application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of diabetic retinopathy risk factors
Time Frame: 1 year
|
risk factors normalization by assessment of hemoglobin A1c percent, blood lipids level and blood pressure level as continuous variables.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation for adhering to treatment recommendations and follow-up
Time Frame: every 4 months
|
Validated health psychology interments will be administer at enrollment and periodically during follow-up.
|
every 4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12-001117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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