Technology Delivered Diabetes-Modified Behavioral Activation Treatment
NCT ID: NCT03593694
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2017-11-06
2019-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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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.
TECH DMBAT Other
Technology delivered diabetes education
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.
TECH DMBAT Active Comparator
Technology delivered diabetes education and home tele monitoring
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.
TECH DM-BAT
Multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.
Interventions
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TECH DM-BAT
Multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.
TECH DMBAT Active Comparator
Technology delivered diabetes education and home tele monitoring
TECH DMBAT Other
Technology delivered diabetes education
Eligibility Criteria
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Inclusion Criteria
* 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
* Participation in other diabetes clinical trials
* Alcohol or drug abuse/dependency
* Active psychosis or acute mental disorder
* Life expectancy \<6 months.
21 Years
ALL
Yes
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Leonard Ehianu Egede
Professor & Chair, Department of Medicine
Principal Investigators
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Leonard E Egede, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PRO00030535
Identifier Type: -
Identifier Source: org_study_id
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