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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK098489-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablets Intervention | Experimental | 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. |
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| Usual Care | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablets Intervention | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities | This will be done to assess self-management behaviors for diabetes. | 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. | 6 months post-randomization |
| Medication Adherence on the Morisky Medication Adherence Scale | Scale will be used to assess specific medication-taking behaviors. | 6 months post-randomization |
| Diet Score on the Rapid Eating and Activity Assessment for Participants | Dietary intake will be assessed. | 6 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Hemoglobin A1c (HbA1c) | Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c. | 6 months post-randomization |
| Low-Density Lipoprotein Cholesterol (LDL-c) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl P Lynch, MD, MPH | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27005766 | Background | Lynch CP, Williams JS, J Ruggiero K, G Knapp R, Egede LE. Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS) for Diabetes. Trials. 2016 Mar 22;17:157. doi: 10.1186/s13063-016-1243-2. |
| Label | URL |
|---|---|
| Protocol paper | View source |
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There are no plans to share IPD during the analysis phase.
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Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for non-fasting lipids.
| 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. | 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). | 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. | 6 months post-randomization |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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