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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

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus, Adult-Onset Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Noninsulin Dependent Diabetes Mellitus, Type II Behavioral: Tablets Intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Actual Study Start Date : August 14, 2014
Actual Primary Completion Date : July 26, 2016
Actual Study Completion Date : August 31, 2016

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   45 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128854


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Cheryl P Lynch, MD, MPH Medical University of South Carolina

Additional Information:
Publications:
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02128854     History of Changes
Other Study ID Numbers: Pro00021502
R03DK098489-01 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share IPD during the analysis phase.

Keywords provided by Medical University of South Carolina:
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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases