Clinical Trials Directory

Trials / Terminated

TerminatedNCT03593694

Technology Delivered Diabetes-Modified Behavioral Activation Treatment

Technology Delivered Diabetes-Modified Behavioral Activation Treatment for AAs With T2DM

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
State University of New York at Buffalo · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Accepted

Summary

The overarching goal of this proposal is to test the efficacy of a multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment (TECH DM-BAT) that incorporates: 1) diabetes education; 2) home telemonitoring; and 3) diabetes modified behavioral activation, delivered by nurses via smartphones is effective in improving metabolic control in African Americans with poorly controlled type 2 diabetes.

Detailed description

Diabetes Mellitus is highly prevalent in the United States (CDC 2014) and African Americans (AA) are disproportionately affected and have higher prevalence, poorer metabolic control and greater risk for complications and death compared to White Americans. Evidence from the literature show that effective interventions for AAs with Type 2 Diabetes Mellitus (T2DM) have multiple components including: education and skills training, nurse case management, and maintain high intensity. However, few large Randomized Clinical Trials (RCT) have tested multi-component interventions that include these key components in AAs with T2DM. Behavioral Activation is a psychotherapeutic process whereby patients are encouraged to identify and schedule structured and enjoyable activities for behavior change that are likely to improve outcomes such as mood, behaviors and quality of life. A brief manualized behavioral activation treatment for depression (BATD), has been modified for diabetes. This study tests a multi-component, high intensity intervention that incorporates several strategies that have been shown to be effective in improving diabetes outcomes in AAs. Nurse case managers will use videoconferencing technology to deliver education, skills training and problem solving for diabetes via smartphones, an approach that has not been used previously in vulnerable and underserved ethnic minority populations.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTECH DM-BATMulti-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.
BEHAVIORALTECH DMBAT Active ComparatorTechnology delivered diabetes education and home tele monitoring
BEHAVIORALTECH DMBAT OtherTechnology delivered diabetes education

Timeline

Start date
2017-11-06
Primary completion
2019-04-30
Completion
2019-04-30
First posted
2018-07-20
Last updated
2024-07-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03593694. Inclusion in this directory is not an endorsement.