Testing an Integrated Care Model Trial

NCT06448429 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-10

No results posted yet for this study

Summary

This study aims to test the use of an adapted collaborative care model for improving the health outcomes of adults diagnosed with type 1 diabetes (T1D). The duration of the study is 18 months with 4 study survey points. Participants will fill out an online survey regarding their psychosocial health and chronic disease management behaviors once every six months over the 18 months, and individuals who are randomly assigned to the study intervention will also consult at least once with a behavioral health consultant during the first year (active intervention period).

Conditions

  • Diabetes Mellitus, Type 1

Interventions

OTHER

Usual care

Participants will have the usual diabetes care at the Grady Diabetes Clinic.

OTHER

Collaborative care model (CoCM)

Collaborative care will include: * Care with a behavioral health consultant (BHC) * Measurement-based mental health care * Systematic caseload reviews * Medical management of depression The BHC will monitor depression and anxiety severity, promote behavioral change with patients through Behavioral Activation, and support the medical management of depression through participation in caseload reviews (I.e., Mental health care plans for individual patients will be reviewed monthly by a multi-disciplinary T1D clinical team and BHC). Depression treatment initiation (if warranted) by a clinician and engagement in mental health care.

Sponsors & Collaborators

  • MQ Mental Health Research

    collaborator UNKNOWN
  • Juvenile Diabetes Research Foundation

    collaborator OTHER
  • Emory University

    lead OTHER

Principal Investigators

  • Leslie Johnson, PhD, MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06448429 on ClinicalTrials.gov