Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-20 @ 12:35 PM
Study NCT ID:
NCT03593694
Status:
TERMINATED
Last Update Posted:
2024-07-12
First Post:
2018-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology Delivered Diabetes-Modified Behavioral Activation Treatment
Sponsor:
State University of New York at Buffalo
Organization:
Study Overview
Official Title:
Technology Delivered Diabetes-Modified Behavioral Activation Treatment for AAs With T2DM
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Service provider challenges precluded intervention delivery.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TECHDMBAT
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: