Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills (TABLETS)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Diabetes Mellitus, Type II; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Type 2

Treatments: Behavioral: Tablets Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02128854

Pro00021502

R03DK098489-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 45 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Tablets Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Tablets Intervention

Usual Care

No Intervention group

Description:

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.