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

NCT03168867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-04-18

Study results available
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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).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BEHAVIORAL

The 3Ms Intervention

The 3 Ms is a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporates principles of Motivational Interviewing. The goal of the 3 Ms intervention is to increase caregiver motivation to supervise children's daily diabetes care. The intervention consists of 3 brief sessions that are delivered at routine diabetes clinic appointments.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Wayne State University

    lead OTHER

Principal Investigators

  • Deborah A Ellis, Ph.D. · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2021-08-03
Completion
2021-08-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168867 on ClinicalTrials.gov