Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Physical Activity Score on the Global Physical Activity Questionnaire
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 45 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Tablets Intervention (Behavioral)
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Quality of Life Using the Medical Outcomes Study Short Form(6 months post-randomization)
- Glycosylated Hemoglobin A1c (HbA1c)(6 months post-randomization)
- Low-Density Lipoprotein Cholesterol (LDL-c)(6 months post-randomization)
- Blood Pressure(6 months post-randomization)
- Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score(6 months post-randomization)