Diabetes Self-Management Models to Reduce Health Disparities (P20-P2)
|ClinicalTrials.gov Identifier: NCT01221090|
Recruitment Status : Completed
First Posted : October 14, 2010
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Other Name: Chronic disease self-management program
Active Comparator: PDA/CDSMP
Combined technology and education
Other Name: PDA + CDSMP
No Intervention: Control
- 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.
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|