- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629434
A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person
October 5, 2021 updated by: State University of New York - Upstate Medical University
This study compares group diabetes education in-person versus via telemedicine
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Diabetes education is important in the treatment of the person with diabetes.
A diabetes self-management education program not only educates the patient and his/her family to the basics of diabetes care but also integrates diabetes care into daily life while providing coping skills to adjust to this chronic illness.
Unfortunately, comprehensive diabetes care is not available to all persons with diabetes.
One obstacle to the provision of comprehensive diabetes care is the unavailability of a diabetes treatment center.
many people with diabetes live too far or do not have the transportation to be able to attend education programs that met national standards.
We have shown that telemedicine is an effective means to provide comprehensive 1:1 individualized diabetes education to persons with diabetes.
We now propose to test the hypothesis that diabetes groups education classes can be provided effectively through telemedicine technology to individuals living in rural areas.
Patients with diabetes will received diabetes education via teleconferencing from our Joslin Diabetes center.
The participants will be assessed before and after diabetes education via telemedicine using measures of glycemia (A1c) and assessments of patient satisfaction, emotional well being, and behavioral change and compared to results from participants attending our diabetes education classes in-person.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13214
- Joslin Diabetes Center Affiliate at SUNY Upstate Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 1 or type 2 diabetes mellitus
- age > 18 years
Exclusion Criteria:
- Profound vision loss
- Severe hearing impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
This arm will receive diabetes education via telemedicine
|
This arm will receive diabetes group education via telemedicine
|
|
Active Comparator: 2
diabetes education in-person
|
In this arm the group of patients with diabetes will receive diabetes education in-person
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
A1c
Time Frame: baseline, 3 mo post intervention, 6 mo post intervention
|
baseline, 3 mo post intervention, 6 mo post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PAID scale
Time Frame: baseline, 3 and 6 months post intervention
|
baseline, 3 and 6 months post intervention
|
|
Diabetes Treatment Satisfaction Questionnaire
Time Frame: Baseline, 3 and 6 months post intervention
|
Baseline, 3 and 6 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
February 25, 2008
First Submitted That Met QC Criteria
March 4, 2008
First Posted (Estimate)
March 6, 2008
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMU IRB # 4510F
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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