Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills (TABLETS)
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|ClinicalTrials.gov Identifier: NCT02128854|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Diabetes Mellitus, Adult-Onset Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Noninsulin Dependent Diabetes Mellitus, Type II||Behavioral: Tablets Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills|
|Actual Study Start Date :||August 14, 2014|
|Actual Primary Completion Date :||July 26, 2016|
|Actual Study Completion Date :||August 31, 2016|
Experimental: Tablets Intervention
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
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).
No Intervention: Usual Care
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.
- Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities [ Time Frame: 6 months post-randomization ]This will be done to assess self-management behaviors for diabetes.
- Physical Activity Score on the Global Physical Activity Questionnaire [ Time Frame: 6 months post-randomization ]Information will be collected to assess physical activity in three domains and sedentary behaviors.
- Medication Adherence on the Morisky Medication Adherence Scale [ Time Frame: 6 months post-randomization ]Scale will be used to assess specific medication-taking behaviors.
- Diet Score on the Rapid Eating and Activity Assessment for Participants [ Time Frame: 6 months post-randomization ]Dietary intake will be assessed.
- Glycosylated Hemoglobin A1c (HbA1c) [ Time Frame: 6 months post-randomization ]Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c.
- Low-Density Lipoprotein Cholesterol (LDL-c) [ Time Frame: 6 months post-randomization ]Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for non-fasting lipids.
- Blood Pressure [ Time Frame: 6 months post-randomization ]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.
- Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score [ Time Frame: 6 months post-randomization ]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).
- Quality of Life Using the Medical Outcomes Study Short Form [ Time Frame: 6 months post-randomization ]We will obtain summary physical and mental health quality of life scores.
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): NCT02128854
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Cheryl P Lynch, MD, MPH||Medical University of South Carolina|