NCT03593694

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

May 14, 2018

Last Update Submit

July 10, 2024

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group 1

OTHER

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

Group 2

ACTIVE COMPARATOR

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

Group 3

EXPERIMENTAL

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

Interventions

TECH DM-BATBEHAVIORAL

Multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.

Group 3
TECH DMBAT Active ComparatorBEHAVIORAL

Technology delivered diabetes education and home tele monitoring

Group 2
TECH DMBAT OtherBEHAVIORAL

Technology delivered diabetes education

Group 1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Leonard E Egede, MD, MS

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Chair, Department of Medicine

Study Record Dates

First Submitted

May 14, 2018

First Posted

July 20, 2018

Study Start

November 6, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)