Testing an Integrated Care Model Trial

NCT06448429 | Active Not Recruiting

• 1 other identifier: STUDY00007247
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Behavioral Health

Outcome Measures

Primary Outcomes (2)

• Proportion of patients achieving improvements in PHQ-9 score

  The proportion of patients achieving improvements in PHQ-9 score \[PHQ-9\<10\] or a ≥50% PHQ-9 score reduction.

  Baseline and 12 months

• Proportion of patients achieving improvement in HbA1c at end of intervention

  Improvement in HbA1c will be considered as HbA1c\<7 or ≥0.5% HbA1c reduction

  Baseline and 12 months

Secondary Outcomes (3)

• Generalized anxiety disorder scale score

  Baseline and 12 months

• Systolic and diastolic blood pressure (BP) measurements

  Baseline and 12 months

• Low-density lipoprotein (LDL) cholesterol

  Baseline and 12 months

Study Arms (2)

Collaborative care group

EXPERIMENTAL

Enrolled participants assigned to the intervention arm will be offered free consultation services with a behavioral health specialist, who is also a licensed clinical social worker. Participants randomized into the intervention group will consult with a behavioral health consultant (BHC) one or more times over the intervention period (based on the assessment of the BHC) via phone or Zoom based on the participant's preference. The BHC will participate in systematic caseload reviews to facilitate the medical management of depression if indicated.

Other: Usual care; Other: Collaborative care model (CoCM)

Usual Care

ACTIVE COMPARATOR

Participants randomized to the usual care will continue their routine clinical care at the diabetes clinic at Grady.

Other: Usual care

Interventions

Usual care OTHER

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

Also known as: Standard of Care (SOC)

Collaborative care group; Usual Care

Collaborative care model (CoCM) OTHER

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.

Also known as: Integrated Care Model

Collaborative care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years) with T1D (based on clinical record diagnosis).

You may not qualify if:

• Patients who do not speak English or have reliable telephone access will be excluded. ---
• Individuals with the presence of severe psychiatric illness (PHQ-9≥20) or active suicidal ideation will also be excluded and referred to specialty care.

Sponsors & Collaborators

• Emory University: lead
• MQ Mental Health Research: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Leslie Johnson, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to lmunoz@emory.edu. To access, the data requesters will sign a data access agreement. Data will be available for 5 years on Emory Dataverse.

Locations

US (1)