Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

NCT02128854 | Completed DMC

• 2 other identifiers: Pro00021502R03DK098489-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (4)

• Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities

  This will be done to assess self-management behaviors for diabetes.

  6 months post-randomization

• Physical Activity Score on the Global Physical Activity Questionnaire

  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

  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

  Dietary intake will be assessed.

  6 months post-randomization

Secondary Outcomes (5)

• 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

Study Arms (2)

Tablets Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

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).

Tablets Intervention

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 27005766 BACKGROUND

Related Links

• Protocol paper

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Cheryl P Lynch, MD, MPH

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: May 1, 2014
• Study Start: August 14, 2014
• Primary Completion: July 26, 2016
• Study Completion: August 31, 2016
• Last Updated: May 9, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)