Clinical trial NCT02128854: Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Official title: Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus, Non-Insulin-Dependent
Diabetes Mellitus, Noninsulin Dependent
Diabetes Mellitus, Type II
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
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities
timeFrame: 6 months post-randomization
measure: Physical Activity Score on the Global Physical Activity Questionnaire
timeFrame: 6 months post-randomization
measure: Medication Adherence on the Morisky Medication Adherence Scale
timeFrame: 6 months post-randomization
measure: Diet Score on the Rapid Eating and Activity Assessment for Participants
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: Glycosylated Hemoglobin A1c (HbA1c)
timeFrame: 6 months post-randomization
measure: Low-Density Lipoprotein Cholesterol (LDL-c)
timeFrame: 6 months post-randomization
measure: Blood Pressure
timeFrame: 6 months post-randomization
measure: Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score
timeFrame: 6 months post-randomization
measure: Quality of Life Using the Medical Outcomes Study Short Form
timeFrame: 6 months post-randomization
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Cheryl P Lynch, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.