Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to Adult Care

Not Applicable

Active, not recruiting

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: Other: Usual Care Model; Other: Diabetes Collaborative Care Model for Young Adults

• Registration Number: NCT05229718
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

In this study, we will determine the feasibility of an innovative care model for young adults with diabetes and compare the primary and secondary outcomes in the innovative model to those in the usual care model for adult diabetes management at Massachusetts General Hospital (MGH) Diabetes Center.

Detailed Description

This study is a quasi-randomized mixed methods evaluation of the implementation of an innovative collaborative care model to assess whether it is feasible and improves indicators of diabetes and mental health, while exploring themes that will inform redesign of the care model to improve healthcare delivery to young adults with diabetes transitioning to the adult care setting. We will compare primary and secondary outcomes in this model to those in the usual care model for adult diabetes management at MGH Diabetes Center. Those who agree to the research study will be asked to complete a series of three survey questionnaires over the timeframe of the study. The electronic health records (EHRs) of these patients who agree to the research study will also be examined. All patients who successfully complete all 3 survey questionnaires will be eligible for a structured interview portion of the study to explore themes that will inform care model redesign.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Type 1 or type 2 diabetes mellitus
• Between ages 18 and 30 years
• Any duration of diabetes
• Must self-manage diabetes
• A new patients at the Massachusetts General Hospital (MGH) Diabetes Center at 50 Staniford Street as of September 1, 2021.
• The patient does not have to be diagnosed with diabetes in youth or have been previously seen at MGH for Children (MGHfC) Pediatric Diabetes Clinic to be included

Exclusion Criteria

• Patients with gestational diabetes, diabetes during pregnancy, MODY, or other forms of diabetes
• Patients with type 2 diabetes who are on no medications (diet-controlled), or metformin only unless they are within one year of diabetes onset
• Patients with significant cognitive, physical, or mental disability requiring that their diabetes care be managed by another individual (i.e. parent, spouse, guardian, nurse, residential facility) more than 25% of the time
• Non-English speaking
• Patients who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Model	Usual Care Model	Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.
Diabetes Collaborative Care Model for Young Adults	Diabetes Collaborative Care Model for Young Adults	Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.

Primary Outcome Measures

Name	Time	Method
Visit completion rate in patients seen in the collaborative care and usual care models	12 months	Mean number of completed visits compared to scheduled visits (visit completion rate) in patients seen in the collaborative care and usual care models
Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID)	12 months	Problems Areas in Diabetes (PAID) is a validated screening tool for diabetes-related distress. Will measure change in PAID scores for both arms. The minimum score is 0 and maximum score is 80. The higher the score, the more severe diabetes-related distress.

Secondary Outcome Measures

Name	Time	Method
Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)	12 months	Generalized Anxiety Disorder Scale-7(GAD-7) is a validated screening tool for anxiety. The minimum score is 0 and maximum score is 21. The higher the score, the more severe anxiety.
Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress	12 months	Problems Areas in Diabetes (PAID) is a validated screening tool for diabetes-related distress. Will measure change in PAID scores for both arms. The minimum score is 0 and maximum score is 80. The higher the score, the more severe diabetes-related distress.
Change in HbA1c	12 months	Change in hemoglobin A1c
Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)	12 months	Diabetes Eating Problem Survey- Revised (DEPS-R) is a validated screening tool for disordered eating behavior for patients with diabetes on insulin therapy. The minimum score is 0 and maximum score is 75. The higher the score, the most severe disordered eating behavior.
Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)	12 months	Patient Health Questionnaire-8 (PHQ-8) is a validated screening tool for depression. The minimum score is 0 and maximum score is 24. The higher the score, the more severe depression.
Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)	12 months	Alcohol Use Disorders Identification Test Consumption (AUDIT-C) is a three-item self-administered screening test for alcohol misuse, validated in adults 18 years and older.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States