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

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tablets Intervention
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring 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

Eligibility Criteria

45 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tablets Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities
This will be done to assess self-management behaviors for diabetes.
Physical Activity Score on the Global Physical Activity Questionnaire
Information will be collected to assess physical activity in three domains and sedentary behaviors.
Medication Adherence on the Morisky Medication Adherence Scale
Scale will be used to assess specific medication-taking behaviors.
Diet Score on the Rapid Eating and Activity Assessment for Participants
Dietary intake will be assessed.

Secondary Outcome Measures

Glycosylated Hemoglobin A1c (HbA1c)
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c.
Low-Density Lipoprotein Cholesterol (LDL-c)
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for non-fasting lipids.
Blood Pressure
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
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
We will obtain summary physical and mental health quality of life scores.

Full Information

First Posted
April 18, 2014
Last Updated
May 5, 2017
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02128854
Brief Title
Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Acronym
TABLETS
Official Title
Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 14, 2014 (Actual)
Primary Completion Date
July 26, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tablets Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tablets Intervention
Intervention Description
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 Outcome Measure Information:
Title
Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities
Description
This will be done to assess self-management behaviors for diabetes.
Time Frame
6 months post-randomization
Title
Physical Activity Score on the Global Physical Activity Questionnaire
Description
Information will be collected to assess physical activity in three domains and sedentary behaviors.
Time Frame
6 months post-randomization
Title
Medication Adherence on the Morisky Medication Adherence Scale
Description
Scale will be used to assess specific medication-taking behaviors.
Time Frame
6 months post-randomization
Title
Diet Score on the Rapid Eating and Activity Assessment for Participants
Description
Dietary intake will be assessed.
Time Frame
6 months post-randomization
Secondary Outcome Measure Information:
Title
Glycosylated Hemoglobin A1c (HbA1c)
Description
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c.
Time Frame
6 months post-randomization
Title
Low-Density Lipoprotein Cholesterol (LDL-c)
Description
Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for non-fasting lipids.
Time Frame
6 months post-randomization
Title
Blood Pressure
Description
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.
Time Frame
6 months post-randomization
Title
Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score
Description
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).
Time Frame
6 months post-randomization
Title
Quality of Life Using the Medical Outcomes Study Short Form
Description
We will obtain summary physical and mental health quality of life scores.
Time Frame
6 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl P Lynch, MD, MPH
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share IPD during the analysis phase.
Citations:
PubMed Identifier
27005766
Citation
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.
Results Reference
background
Links:
URL
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1243-2
Description
Protocol paper

Learn more about this trial

Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

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