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

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ClinicalTrials.gov Identifier: NCT02128854
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE April 18, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date May 9, 2017
Actual Study Start Date  ICMJE August 14, 2014
Actual Primary Completion Date July 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
  • 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.
  • 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.
  • Medication Adherence on the Morisky Medication Adherence Scale [ Time Frame: 6 months post-randomization ]
    Scale will be used to assess specific medication-taking behaviors.
  • Diet Score on the Rapid Eating and Activity Assessment for Participants [ Time Frame: 6 months post-randomization ]
    Dietary intake will be assessed.
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • 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.
  • Diet Score on the Rapid Eating and Activity Assessment for Participants [ Time Frame: 6 months post-randomization ]
    Dietary intake will be assessed.
  • Medication Adherence on the Morisky Medication Adherence Scale [ Time Frame: 6 months post-randomization ]
    Scale will be used to assess specific medication-taking behaviors.
  • 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.
Change History Complete list of historical versions of study NCT02128854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Official Title  ICMJE Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Adult-Onset
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Diabetes Mellitus, Noninsulin Dependent
  • Diabetes Mellitus, Type II
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Tablets Intervention
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2016
Actual Primary Completion Date July 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02128854
Other Study ID Numbers  ICMJE Pro00021502
R03DK098489-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There are no plans to share IPD during the analysis phase.
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Cheryl P Lynch, MD, MPH Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP