Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary questions such as the relationship between treatment dose and treatment outcome and what factors affect the actual delivery of the intervention in the clinics (staff burden, workflow interference etc).

Key facts

Study ID

NCT03168867

Run by

Wayne State University

People needed

149

Starts

2017-09-25

Expected to finish

2021-08-03

Last updated by the study team

2023-04-18

Who can join

Age: 10 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 10 years 0 months - 15 years, 11 months
• Diagnosed with Type 1 diabetes
• Diagnosed for at least 6 months
• African American
• Residence within 30 miles of a recruitment site (Children's Hospital of Michigan, Ann and Robert H. Lurie Children's Hospital of Chicago, Children's Hospital University of Illinois, or La Rabida Children's Hospital of Chicago)
• Primary caregiver willing to participate

You may not qualify if…

• Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)
• Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
• Inability to speak or read English
• Child is in out-of-home placement

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Children's Hospital University of Illinois — Chicago, Illinois, United States
• UChicago Medicine Comer Children's Hospital — Chicago, Illinois, United States
• La Rabida Children's Hospital — Chicago, Illinois, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Ascension St. John Children's Hospital — Detroit, Michigan, United States
• William Beaumont Children's Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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