- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593694
Technology Delivered Diabetes-Modified Behavioral Activation Treatment (TECHDMBAT)
Technology Delivered Diabetes-Modified Behavioral Activation Treatment for AAs With T2DM
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥21 years
- Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit;
- Self-identified as AA
- Subject must be willing to use the FORA monitoring system for 6 months
- Subject must be willing to use the study assigned smartphone including videoconferencing, lifestyle monitoring and medication monitoring apps for 6 months
- Subjects must be able to communicate in English
- Subjects must have access to a landline or Ethernet for FORA data uploads for the study period.
Exclusion Criteria:
- Mental confusion on interview suggesting significant dementia
- Participation in other diabetes clinical trials
- Alcohol or drug abuse/dependency
- Active psychosis or acute mental disorder
- Life expectancy <6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group 1
Arm: Other: Group 1 Participants in this group will receive the culturally tailored education booklet titled "Your Guide to Sugar Diabetes".
In addition, subjects will complete 10 sessions of diabetes education delivered weekly via videoconferencing lasting 60 minutes each session as detailed above.
|
Technology delivered diabetes education
|
Active Comparator: Group 2
Arm: Active Comparator: Group 2 Participants in this group will receive as detailed above, the culturally tailored education booklet titled "My Guide to Sugar Diabetes".
In addition, subjects will complete 10 sessions of diabetes education delivered weekly via videoconferencing lasting 60 minutes each session.
Patients will also be assigned the FORA Test-n-Go Series Blood Glucose and Blood Pressure monitors and provided glucose test strips to allow testing at least once a day during the initial face-to-face session.
|
Technology delivered diabetes education and home tele monitoring
|
Experimental: Group 3
Arm: Experimental: Group 3 The intervention has 3 components: 1) diabetes education; 2) home telemonitoring; and 3) diabetes modified behavioral activation, delivered by nurses via smartphones.
Trained nurses will deliver the TECH DM-BAT intervention via videoconferencing technology on smartphones.
|
Multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months
Time Frame: baseline, 3-months, 6-months
|
Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months
|
baseline, 3-months, 6-months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00030535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaRecruiting
Clinical Trials on TECH DMBAT Other
-
University of South CarolinaCompleted
-
Cindy Blair, PhD, MPHAmerican Cancer Society, Inc.; University of New Mexico Cancer CenterCompleted
-
University of Alabama at BirminghamNot yet recruitingType 2 Diabetes | Physical Disability
-
Mayo ClinicCompleted
-
University of South CarolinaUnknown
-
The University of Texas Health Science Center,...National Institute of Mental Health (NIMH)CompletedSexually Transmitted Diseases | HIVUnited States
-
Ohio State UniversityCompletedOutpatient | Physician-Patient Relations | Inpatient Facility Diagnoses | Electronic Health RecordsUnited States
-
Norwegian University of Science and TechnologyCompletedMusculoskeletal Pain | Chronic PainNorway
-
Norwegian University of Science and TechnologyCompletedObesity | OverweightNorway
-
Mansoura UniversityUnknownBladder Cancer | Infection | Complication | Oncology | Radical Cystectomy | Muscle InvasiveEgypt