Diabetes Self-Management Models to Reduce Health Disparities (P20-P2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01221090 |
Recruitment Status
:
Completed
First Posted
: October 14, 2010
Results First Posted
: October 14, 2013
Last Update Posted
: October 14, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Behavioral: PDA Behavioral: CDSMP Behavioral: PDA/CDSMP | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 376 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Employing Diabetes Self-Management Models to Reduce Health Disparities in Texas |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Personal Digital Assistant
Individuals in this arm were taught to use a diabetes self-care software, Diabetes Pilot™ (Digital Altitudes, Arlington Heights, IL), developed for PalmOS® (Palm, Sunnyvale, CA) which was loaded on to compatible PDAs, the Tungsten™ E2 handheld device. The Diabetes Pilot allowed participants to monitor their blood glucose, blood pressure, medication usage, physical activity, and dietary intake by tracking these measures in an electronic diary.
|
Behavioral: PDA
Technological assistance
Other Name: Personal digital assistant
|
Active Comparator: CDSMP
6-week, classroom-based program for diabetes self-management. The CDSMP, developed by Stanford University, equipped participants with the education and skill sets needed to take a more proactive approach in managing their chronic condition(s) and related symptoms.
|
Behavioral: CDSMP
6-week classes
Other Name: Chronic disease self-management program
|
Active Comparator: PDA/CDSMP
Combined intervention
|
Behavioral: PDA/CDSMP
Combined technology and education
Other Name: PDA + CDSMP
|
No Intervention: Control
Usual Care
|
- HbA1c [ Time Frame: 12 months ]Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation.
- BMI [ Time Frame: 12 months ]Body mass index
- Patient Self-reported Perceived Health Status [ Time Frame: 12 months ]
- Diabetes-related Behaviors [ Time Frame: 12 months ]Participants were asked the number of days in the past 7 which they participated in various diabetes self-care activities on diet, exercise, home blood glucose monitoring, and foot care.
- Quality of Life (QOL) [ Time Frame: 12 months ]Participants where asked the number of days in the past 30 days in which their physical (phys) and/or mental was not good, and whether their usual activity was affected by their physical/mental health.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221090
United States, Texas | |
Scott & White Clinic | |
Temple, Texas, United States, 76504 |
Principal Investigator: | Samuel N Forjuoh, MD MPH DrPH | Scott & White |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sam Forjuoh, Professor & Director of Research, Scott and White Hospital & Clinic |
ClinicalTrials.gov Identifier: | NCT01221090 History of Changes |
Other Study ID Numbers: |
071304 P20MD002295 ( U.S. NIH Grant/Contract ) |
First Posted: | October 14, 2010 Key Record Dates |
Results First Posted: | October 14, 2013 |
Last Update Posted: | October 14, 2013 |
Last Verified: | August 2013 |
Keywords provided by Sam Forjuoh, Scott and White Hospital & Clinic:
Type 2 diabetes Health disparities Central Texas PDA CDSMP |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |