Diabetes Mellitus, Type 1
Conditions
Keywords
Behavioral Health
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).
Detailed description
Type 1 diabetes (T1D) is a lifelong condition that requires consistent monitoring and management, increasing people's risk for common mental disorders that worsen diabetes self-care. Both depression and diabetes can be managed with behavioral interventions, however, they are rarely provided alongside routine diabetes care for people with T1D. In this research study, the investigators aim to evaluate the implementation and effectiveness outcomes of a collaborative care model that uses a Behavioral Health Consultant (BHC) to support lifestyle management among adults with T1D receiving diabetes care at the Grady Diabetes Clinic. A trained clinical research coordinator will screen interested patients seeking treatment at the Grady Diabetes Center and conduct outreach to individuals who have been identified as having T1D within the Grady Diabetes Center's patient population. Participants in the intervention group will engage with a behavioral health consultant (BHC) not affiliated with Grady who will work with them to establish personalized health goals and identify ways to manage stress and promote healthy behaviors as means to support their mental and physical health and meet their set goals (i.e., behavioral activation). Each session will be conducted over the telephone or Zoom and last 30-60 minutes, with the number and frequency of meetings established through discussions between the patient and BHC (typically 2-3 sessions for one year). Checklist and summary case reporting templates will be used to track intervention fidelity. The BHC will also participate in ongoing Zoom calls with the multi-disciplinary T1D clinical team at the Grady Diabetes Center once a month to provide updates on patients' behavioral health plans. Transitioning patients from the active intervention will involve discussions with the care team to ensure continued patient support. In cases of active suicidal ideation, the study team will notify the patient's usual diabetes care provider and the individual will be referred to psychiatric services at Grady.
Interventions
OTHERUsual care
Participants will have the usual diabetes care at the Grady Diabetes Clinic.
OTHERCollaborative 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
Emory University
MQ Mental Health Research
Juvenile Diabetes Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults (≥18 years) with T1D (based on clinical record diagnosis).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving improvements in PHQ-9 score | Baseline, 12 months, and 18 months | The proportion of patients achieving improvements in PHQ-9 score \[PHQ-9\<10\] or a ≥50% PHQ-9 score reduction. |
| Proportion of patients achieving improvement in HbA1c at end of intervention | Baseline, 12 months, and 18 months | Improvement in HbA1c will be considered as HbA1c\<7 or ≥0.5% HbA1c reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized anxiety disorder scale score | Baseline, 12 months, and 18 months | Researchers will use the Generalized anxiety disorder (GAD)-7, a 7-item scale with reporting scores from 0 to 3 on all the questions. It investigates how often the patient has been bothered by seven different symptoms of anxiety during the last two weeks with response options such as: " not at all," " several days '," more than half the days," and " nearly daily " scored as 0, 1, 2, and 3, respectively. The GAD-7 is scored by adding the scores for all 7 items, giving a total score from 0 to 21. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively. Further evaluation is recommended when the score is 10 or greater. |
| Systolic and diastolic blood pressure (BP) measurements | Baseline, 12 months, and 18 months | Systolic and diastolic blood pressure (SBP and DBP) will be extracted from participants' medical records. |
| Low-density lipoprotein (LDL) cholesterol | Baseline, 12 months, and 18 months | LDL cholesterol data will be extracted from participants' medical records. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeslie Johnson, PhD, MPH
Emory University
Outcome results
None listed