Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

Diabetes Mellitus, Type 2 Clinical Trial

— TABLETS  

Official title:

Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128854
• Other study ID #: Pro00021502
• Secondary ID: R03DK098489-01
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: May 5, 2017
• Start date: August 14, 2014
• Est. completion date: August 31, 2016

Study information

• Verified date: September 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2016
• Est. primary completion date: July 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Adult-Onset
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Noninsulin Dependent
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

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).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Medication Adherence on the Morisky Medication Adherence Scale	Scale will be used to assess specific medication-taking behaviors.	6 months post-randomization
Primary	Diet Score on the Rapid Eating and Activity Assessment for Participants	Dietary intake will be assessed.	6 months post-randomization
Secondary	Glycosylated Hemoglobin A1c (HbA1c)	Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c.	6 months post-randomization
Secondary	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.	6 months post-randomization
Secondary	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.	6 months post-randomization
Secondary	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).	6 months post-randomization
Secondary	Quality of Life Using the Medical Outcomes Study Short Form	We will obtain summary physical and mental health quality of life scores.	6 months post-randomization

External Links

•   Protocol paper