Status:
COMPLETED
Diabetes Self-Management Models to Reduce Health Disparities
Lead Sponsor:
Scott and White Hospital & Clinic
Collaborating Sponsors:
Texas A&M University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the effectiveness of two different diabetes self-management approaches (Personal Digital Assistant-based intervention \& Chronic Disease Self-Management Program) to reduce health dispariti...
Detailed Description
Despite concerted federal and state attempts to reduce health disparities over the past decades substantial disparities in reported rates of chronic disease for minorities still exist. In particular, ...
Eligibility Criteria
Inclusion
- Patients with T2DM, including those who require insulin therapy, aged \>18 years (eliminates the need to obtain assent for minors who are also dependent on their parents).
- Last measured HbA1c value of \> 7.5% (this study hopes to show an improvement in the control of patient's diabetes, and not focused on patients who already show evidence of good disease control).
- Willingness and ability to attend one initial research visit and semi-annual routine follow-up visits over a 24-month period. The follow-up visits include height, weight, and blood pressure measurement and a survey. Surveys may be conducted by phone interview or mail when a follow-up visit can not be scheduled.
- Ability to read, write, and speak English at least at a grade 8 level so as to be able to engage in self-monitoring and use the commercial diabetes management software program (Diabetes Pilot), which is available only in English. For those with lower-literacy, assistance in filling out forms and understanding required intervention protocols will be provided, and use of a "buddy" will be recommended.
Exclusion
- Not willing to sign an informed consent or be randomized to any of the four treatment/control groups, (we want to minimize any upfront treatment biases, while adhering to human subject protocols).
- Currently, documented severe alcoholism or drug abuse that is \< 6 months ago (concerns that this problem is likely to significantly affect their ability and likelihood to comply with the study requirements over the course of the 24 months).
- Female patients who are pregnant or planning to become pregnant within 12 months (in pregnancy, type 2 diabetes is managed in a completely different manner than in non-pregnant patients).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT01221090
Start Date
January 1 2009
End Date
May 1 2012
Last Update
October 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Scott & White Clinic
Temple, Texas, United States, 76504