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

Primary Purpose

Type 1 Diabetes, Type 2 Diabetes

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diabetes Collaborative Care Model for Young Adults

Usual Care Model

About this trial

This is an interventional health services research trial for Type 1 Diabetes focused on measuring Young Adults, Emerging Adults, Diabetes

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Usual Care Model

Diabetes Collaborative Care Model for Young Adults

Arm Description

Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.

Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.

Outcomes

Primary Outcome Measures

Visit completion rate in patients seen in the collaborative care and usual care models

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)

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

Change in HbA1c

Change in hemoglobin A1c

Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)

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 anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)

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

Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)

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 alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)

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.

Full Information

NCT ID

NCT05229718

First Posted

January 27, 2022

Last Updated

October 23, 2023

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05229718

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Type 2 Diabetes

Keywords

Young Adults, Emerging Adults, Diabetes

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care Model

Arm Type

Active Comparator

Arm Description

Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.

Arm Title

Diabetes Collaborative Care Model for Young Adults

Arm Type

Active Comparator

Arm Description

Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.

Intervention Type

Other

Intervention Name(s)

Diabetes Collaborative Care Model for Young Adults

Intervention Description

We designed a diabetes collaborative care model for young adults that incorporates a mental health provider alongside a diabetes care provider during joint office visits to facilitate screening and treatment of psychosocial determinants of diabetes management. The Massachusetts General Hospital (MGH) Diabetes Center will be piloting this model with a multi-disciplinary team of diabetologists, nurse practitioners, diabetes nurse educators, and mental health provider. Patients scheduled to be seen in the diabetes collaborative care model will continue to follow in the diabetes collaborative care model, with follow up visits every 3-4 months. All patients will receive routine diabetes care with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers.

Intervention Type

Other

Intervention Name(s)

Usual Care Model

Intervention Description

Patients enrolled in this arm will receive routine diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center, with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers. In the usual care model, behavioral/mental health and social work services are available on a referral basis and are not integrated into a patients' routine appointment. Screening and treatment of psychosocial determinants of diabetes management are at done at the discretion of the patients' provider. Frequency of follow up visits is at the discretion of the patients' provider.

Primary Outcome Measure Information:

Title

Visit completion rate in patients seen in the collaborative care and usual care models

Description

Mean number of completed visits compared to scheduled visits (visit completion rate) in patients seen in the collaborative care and usual care models

Time Frame

12 months

Title

Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID)

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in HbA1c

Description

Change in hemoglobin A1c

Time Frame

12 months

Title

Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)

Description

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.

Time Frame

12 months

Title

Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)

Description

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.

Time Frame

12 months

Title

Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress

Description

Time Frame

12 months

Title

Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)

Description

Time Frame

12 months

Title

Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah J Wexler, MD, MSc

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pilot and Feasibility study, no plan to share IPD

Learn more about this trial

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

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