Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Type II; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Tablets Intervention

• Registration Number: NCT02128854
• Lead Sponsor: Medical University of South Carolina

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 Timeline

• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Study Start: 2014-08-14
• Primary Completion: 2016-07-26
• Study Completion: 2016-08-31
• Status Verified: 2016-09
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tablets Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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).

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States