Clinical trial NCT05229718: Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to Adult Care
Official title: Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to the Adult Diabetes Care Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Young Adults
Emerging Adults
Diabetes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visit completion rate in patients seen in the collaborative care and usual care models
timeFrame: 12 months
measure: Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID)
timeFrame: 12 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 12 months
measure: Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)
timeFrame: 12 months
measure: Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)
timeFrame: 12 months
measure: Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress
timeFrame: 12 months
measure: Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)
timeFrame: 12 months
measure: Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Deborah J Wexler, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: