Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

Sponsors

Lead Sponsor: Medical University of South Carolina

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source 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

Overall Status Completed
Start Date August 14, 2014
Completion Date August 31, 2016
Primary Completion Date July 26, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities 6 months post-randomization
Physical Activity Score on the Global Physical Activity Questionnaire 6 months post-randomization
Medication Adherence on the Morisky Medication Adherence Scale 6 months post-randomization
Diet Score on the Rapid Eating and Activity Assessment for Participants 6 months post-randomization
Secondary Outcome
Measure Time Frame
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
Quality of Life Using the Medical Outcomes Study Short Form 6 months post-randomization
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Tablets Intervention

Description: 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).

Arm Group Label: Tablets Intervention

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

Gender: All

Minimum Age: 45 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Cheryl P Lynch, MD, MPH Principal Investigator Medical University of South Carolina
Location
Facility: Medical University of South Carolina
Location Countries

United States

Verification Date

September 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tablets Intervention

Type: Experimental

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.

Label: Usual Care

Type: No Intervention

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.

Acronym TABLETS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov