Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448429
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-04
Brief Title:
Testing an Integrated Care Model Trial
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Evaluating the Integration of Mental Health Care Into the Treatment of Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 peoples 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 Centers 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 ie 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 patients usual diabetes care provider and the individual will be referred to psychiatric services at Grady
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 Centers 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 ie 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 patients usual diabetes care provider and the individual will be referred to psychiatric services at Grady
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None