Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type II
Conditions
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II, African Americans, Blacks, Non-Hispanic Blacks, Randomized Control Trial, Controlled Clinical Trial, Behavioral Research, Behavioral Medicine
Brief summary
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
Detailed description
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
Interventions
BEHAVIORALTablets 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).
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥45 years * Clinical diagnosis of diabetes with HbA1c ≥8% and either diagnosis of hyperlipidemia with LDL \>100mg/dL or hypertension with BP \>140/80mmHg * Self-identified as African American * Residence in a 4G cellular service area * Able to communicate in English
Exclusion criteria
* Cognitive impairment * Active alcohol or drug abuse/dependency * Acute decompensation of chronic conditions precluding participation * Participation in other diabetes clinical trials * A life expectancy \<6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities | 6 months post-randomization | This will be done to assess self-management behaviors for diabetes. |
| Physical Activity Score on the Global Physical Activity Questionnaire | 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 | 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 | 6 months post-randomization | Dietary intake will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated Hemoglobin A1c (HbA1c) | 6 months post-randomization | Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c. |
| Quality of Life Using the Medical Outcomes Study Short Form | 6 months post-randomization | We will obtain summary physical and mental health quality of life scores. |
| Low-Density Lipoprotein Cholesterol (LDL-c) | 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 | 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 | 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). |
Countries
United States
Outcome results
None listed