N/A
Completed N=149
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
Source: ClinicalTrials.gov NCT03168867 ↗Enrolled (actual)
149
Serious AEs
35.6%
Results posted
Apr 2023
Primary outcomePrimary: Glycemic Control — 11.51; 11.48; 11.55; 11.14 percentage of glycosylated hemoglobin — p=<.05
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control |
11.51; 11.48; 11.55; 11.14; 11.47; 11.09 | <.05 sig |
| SECONDARY Regimen Adherence (Objective) |
— | — |
| SECONDARY Diabetes Management (Self-reported) |
— | — |
| SECONDARY Parental Monitoring of Diabetes Care (Self-reported) |
— | — |
| SECONDARY Diabetes- Specific Family Functioning (Self-reported) |
— | — |
| SECONDARY Adolescent Depression (Self-reported) |
— | — |
| SECONDARY Executive Functioning (Self-reported) |
— | — |
| SECONDARY Cost Analysis (Self-reported) |
— | — |
| SECONDARY Diabetes Emotional Distress (Self-reported) |
— | — |
| SECONDARY Household Chaos (Self-reported) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03168867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.