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Collaborative Care Model for Diabetes

N/A
Waitlist Available
Led By Deborah J Wexler, MD, MSc
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 1 or type 2 diabetes mellitus
Between ages 18 and 30 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will compare an innovative care model for young adults with diabetes to the usual care model at MGH Diabetes Center.

Who is the study for?
This trial is for young adults aged 18-30 with Type 1 or Type 2 diabetes, who manage their own diabetes and are new patients at MGH Diabetes Center as of September 2021. It's not for pregnant individuals, non-English speakers, those with other forms of diabetes or significant disabilities requiring others to manage their care.Check my eligibility
What is being tested?
The study tests a new Diabetes Collaborative Care Model against the usual care model at MGH Diabetes Center. The goal is to see how well the innovative model works and compare health outcomes between the two groups.See study design
What are the potential side effects?
Since this trial compares different models of care rather than medications, there aren't direct side effects like you'd expect from drugs. However, changes in healthcare management could impact patient stress levels or satisfaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have diabetes (type 1 or type 2).
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I am between 18 and 30 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID)
Visit completion rate in patients seen in the collaborative care and usual care models
Secondary outcome measures
Change in HbA1c
Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress
Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Usual Care ModelActive Control1 Intervention
Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.
Group II: Diabetes Collaborative Care Model for Young AdultsActive Control1 Intervention
Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,790 Total Patients Enrolled
Deborah J Wexler, MD, MScPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the core goals that this research endeavor is seeking to accomplish?

"Throughout the 12 month duration of this trial, researchers aim to measure primary outcomes related to diabetes-related distress with the Problem Areas in Diabetes (PAID) scale. Secondary objectives include tracking changes in HbA1c and alcohol use via Alcohol Use Disorders Identification Test Consumption (AUDIT-C), as well as Generalized Anxiety Disorder Scale-7(GAD-7). GAD-7 scores range from 0 - 21; higher numbers suggest more severe anxiety symptoms."

Answered by AI

Is the eligibility for this clinical trial restricted to individuals younger than 20 years old?

"This clinical trial is only available to applicants aged between 18 and 30. For those aged under 18, there are 218 options for medical trials; conversely, 1137 exist for seniors over the age of 65."

Answered by AI

Do I meet the criteria for participating in this experiment?

"In order to be considered, applicants must have been diagnosed with type 2 diabetes mellitus and fall between 18-30 years old. Currently, the trial is looking for approximately 50 participants."

Answered by AI

Are there any open slots for the trial currently available?

"Affirmative. Information on clinicaltrials.gov affirms that this medical trial, first posted in October 1st 2021 is actively seeking participants. Enrollment requires the collection of 50 participants from a single site."

Answered by AI

What is the participant limit for this clinical research initiative?

"Indeed, the details on clinicaltrials.gov suggest this medical trial is still accepting participants. It was first posted in October 2021 and has been amended as recently as February 2022. 50 individuals are needed from only one location for enrollment purposes."

Answered by AI
~4 spots leftby Jun 2024