An interventional study of Tablets Intervention in Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset and Diabetes Mellitus, Non-Insulin-Dependent, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 45 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural African American (AA) adults in South Carolina (SC) for assessing the usefulness of tablet-based resources in good diabetes self-management behaviors, and (2) to test a tablet-aided intervention for improving diabetes self-management behaviors
The proposed study will assess the feasibility of recruitment of African American adults residing in rural South Carolina who will assist with improving the usability of tablet computers. In addition, we will implement a pilot trial of the TABLETS (Tablet-Aided BehavioraL intervention Effect on Self-management skills) intervention for diabetes, using motivational strategies, among rural African Americans. The proposed project is designed to address 3 important issues: recruitment for a hard-to-reach population, utility of technology-enabled intervention, and development of a tablet-aided intervention tailored to understand best practices for diabetes self-management
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 60 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Exclusion Criteria:
Individuals randomized to this arm will receive: 1) peripheral devices for monitoring blood glucose, blood pressure, and weight; 2) 8 weekly tablet-delivered education and skills training sessions; 3) two booster sessions delivered via tablet-based videoconferencing at 3 and 6 months.
Behavioral: Tablets Intervention
Apart from study visits, individuals randomized to the Usual Care group will receive usual care for diabetes management as provided by their primary care physician. The provider will be responsible for determining changes in the treatment regimen and determining the timing of follow-up visits for diabetes care. Between scheduled office encounters, contact will be initiated by the individual.
The TABLET intervention adds a novel tablet-based delivery mechanism to provide real-time videoconferencing education about diabetes self-management behaviors to high-risk, low-income African American (AA) adults with diabetes. Cardiovascular disease (CVD) knowledge/ information modules consist of materials developed from a CVD patient education booklet adapted from Maine Heart Center of Maine Health and supplemented by clinical guidelines to specifically address behavioral risk factors. Motivation/behavioral skills training modules consist of patient activation (asking questions to providers), patient empowerment (CVD responsibility contracts, flow charts for lab results), and behavioral skills training (self-monitoring, goal-setting).
Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities
This will be done to assess self-management behaviors for diabetes.
Time frame: 6 months post-randomization
Physical Activity Score on the Global Physical Activity Questionnaire
Information will be collected to assess physical activity in three domains and sedentary behaviors.
Time frame: 6 months post-randomization
Medication Adherence on the Morisky Medication Adherence Scale
Scale will be used to assess specific medication-taking behaviors.
Time frame: 6 months post-randomization
Diet Score on the Rapid Eating and Activity Assessment for Participants
Dietary intake will be assessed.
Time frame: 6 months post-randomization
Glycosylated Hemoglobin A1c (HbA1c)
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c.
Time frame: 6 months post-randomization
Low-Density Lipoprotein Cholesterol (LDL-c)
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for non-fasting lipids.
Time frame: 6 months post-randomization
Blood Pressure
Blood pressure (BP) readings will be obtained using automated BP monitors. The device will be programmed to take 3 readings at 2 minute intervals, and give an average of the 3 BP readings.
Time frame: 6 months post-randomization
Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score
This score will be used to estimate the 10-year risk for coronary heart disease outcomes (i.e., heart attack, death) according to 7 factors (age, gender, total cholesterol, high-density lipoprotein cholesterol, systolic blood pressure, high blood pressure medication use, and smoking status).
Time frame: 6 months post-randomization
Quality of Life Using the Medical Outcomes Study Short Form
We will obtain summary physical and mental health quality of life scores.
Time frame: 6 months post-randomization
Plan to share: No — There are no plans to share IPD during the analysis phase.
Ran from Aug 2014 to primary completion in Jul 2016, 23 months.
Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 23 months is close to that.
Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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