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

May 5, 2017 updated by: Medical University of South Carolina
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Tablets Intervention
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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post-randomization
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.
6 months post-randomization
Medication Adherence on the Morisky Medication Adherence Scale
Time Frame: 6 months post-randomization
Scale will be used to assess specific medication-taking behaviors.
6 months post-randomization
Diet Score on the Rapid Eating and Activity Assessment for Participants
Time Frame: 6 months post-randomization
Dietary intake will be assessed.
6 months post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Hemoglobin A1c (HbA1c)
Time Frame: 6 months post-randomization
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c.
6 months post-randomization
Low-Density Lipoprotein Cholesterol (LDL-c)
Time Frame: 6 months post-randomization
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for non-fasting lipids.
6 months post-randomization
Blood Pressure
Time Frame: 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.
6 months post-randomization
Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score
Time Frame: 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).
6 months post-randomization
Quality of Life Using the Medical Outcomes Study Short Form
Time Frame: 6 months post-randomization
We will obtain summary physical and mental health quality of life scores.
6 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

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

Investigators

  • Principal Investigator: Cheryl P Lynch, MD, MPH, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2014

Primary Completion (Actual)

July 26, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00021502
  • R03DK098489-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share IPD during the analysis phase.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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