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Behavioural Intervention

Collaborative Care Model for Type 1 Diabetes

N/A

Recruiting

Led By Leslie Johnson, PhD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a new approach to care can help improve the health of adults with type 1 diabetes. The study will last for 18 months and involve participants completing online surveys every six

Who is the study for?

Adults over 18 with type 1 diabetes can join this trial. It's not for those who have severe psychiatric illness, active suicidal thoughts, or don't speak English/have phone access.

What is being tested?

The study is comparing usual care for type 1 diabetes against a collaborative care model (CoCM) that includes regular online surveys and consultations with a behavioral health consultant.

What are the potential side effects?

Since the interventions involve healthcare management rather than medication, there are no direct side effects; however, participants may experience stress or discomfort from additional surveys and consultations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult diagnosed with Type 1 Diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients achieving improvement in HbA1c at end of intervention

Proportion of patients achieving improvements in PHQ-9 score

Secondary study objectives

Generalized anxiety disorder scale score

Low-density lipoprotein (LDL) cholesterol

Systolic and diastolic blood pressure (BP) measurements

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Collaborative care groupExperimental Treatment2 Interventions

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.

Group II: Usual CareActive Control1 Intervention

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

0 / 1Eligibility criteria met