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Technology Delivered Diabetes-Modified Behavioral Activation Treatment (TECHDMBAT)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TECH DM-BAT
TECH DMBAT Active Comparator
TECH DMBAT Other
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months
Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months

Secondary Outcome Measures

Full Information

First Posted
May 14, 2018
Last Updated
June 16, 2021
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03593694
Brief Title
Technology Delivered Diabetes-Modified Behavioral Activation Treatment
Acronym
TECHDMBAT
Official Title
Technology Delivered Diabetes-Modified Behavioral Activation Treatment for AAs With T2DM
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Service provider challenges precluded intervention delivery.
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TECH DM-BAT
Intervention Description
Multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.
Intervention Type
Behavioral
Intervention Name(s)
TECH DMBAT Active Comparator
Intervention Description
Technology delivered diabetes education and home tele monitoring
Intervention Type
Behavioral
Intervention Name(s)
TECH DMBAT Other
Intervention Description
Technology delivered diabetes education
Primary Outcome Measure Information:
Title
Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months
Description
Change from Baseline Hemoglobin A1c (HbA1c) at 3 and 6 months
Time Frame
baseline, 3-months, 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard E Egede, MD, MS
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Technology Delivered Diabetes-Modified Behavioral Activation Treatment

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