Mobile Application to Enhance Diabetic Care

Sponsor

University of California, Los Angeles (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01983917

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective study to evaluate whether or not an internet application to coordinate and record diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical care team and 3. ophthalmology vision care team will decrease vision loss and blindness due to diabetic retinopathy. The aims will be measured through health psychology instruments to assess the effect of the application on management, motivation to control their disease, and commitment to comply with treatment. We will also measure objective health outcomes including Blood Pressure, Blood lipids level, hemoglobin A1c level, and Visual Acuity.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: Diabetes Mobile Application	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Clinical Trial of Mobile Application to Enhance Diabetic Health Care

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Use of the Diabetes Application	Behavioral: Diabetes Mobile Application

Arm

Intervention/Treatment

Other: Use of the Diabetes Application

Behavioral: Diabetes Mobile Application

Outcome Measures

Primary Outcome Measures

Change of diabetic retinopathy risk factors [1 year]
risk factors normalization by assessment of hemoglobin A1c percent, blood lipids level and blood pressure level as continuous variables.

Secondary Outcome Measures

Motivation for adhering to treatment recommendations and follow-up [every 4 months]
Validated health psychology interments will be administer at enrollment and periodically during follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Inability or unwillingness of the patient's diabetes medical care or ophthalmology vision care team to participate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jules Stein Eye Institute	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Irena Tsui, M.D., Assistant Professor of Ophthalmology, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01983917

Other Study ID Numbers:

12-001117

First Posted:

Nov 14, 2013

Last Update Posted:

May 12, 2016

Last Verified:

May 1, 2016

Keywords provided by Irena Tsui, M.D., Assistant Professor of Ophthalmology, University of California, Los Angeles

diabetes

mobile application

diabetic retinopathy

Study Results

No Results Posted as of May 12, 2016