Technology Delivered Diabetes-Modified Behavioral Activation Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: TECH DM-BAT
* Behavioral: TECH DMBAT Active Comparator
* Behavioral: TECH DMBAT Other


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>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. | Behavioral: TECH DMBAT Other<br>* Technology delivered diabetes education<br>|
| Active Comparator: Group 2<br>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. | Behavioral: TECH DMBAT Active Comparator<br>* Technology delivered diabetes education and home tele monitoring<br>|
| Experimental: Group 3<br>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. | Behavioral: TECH DM-BAT<br>* Multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months | Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months | baseline, 3-months, 6-months |