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Completed

NCT Number: NCT02128854

Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Diabetes Mellitus, Adult-Onset Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Noninsulin Dependent Diabetes Mellitus, Type II Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tablets Intervention

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

  3. Medication Adherence on the Morisky Medication Adherence Scale

    Time frame: 6 months post-randomization

    Scale will be used to assess specific medication-taking behaviors.

  4. Diet Score on the Rapid Eating and Activity Assessment for Participants

    Time frame: 6 months post-randomization

    Dietary intake will be assessed.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

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

Registry information

Acronym: TABLETS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 1, 2014
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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