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

April 17, 2023 updated by: Deborah Ellis, Ph.D., Wayne State University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted at 3 clinics in the Detroit area (Children's Hospital of Michigan (CHM); Ascension St. John Children's Hospital; William Beaumont Children's Hospital) and 4 clinics in the Chicago area. Wayne State University (WSU) will function as the coordinating center for the trial and will be responsible for overseeing the adequacy all aspects of trial management, including recruitment, retention, data collection, data management and statistical analyses. 212 African American (AA) adolescents with type 1 diabetes and their primary caregivers will be enrolled across all sites (half will be enrolled at WSU and half at the 4 Chicago sites). Families will be randomized to one of two arms: The 3Ms intervention (parental motivation for supervision of adolescent DSM) or standard educational control. In the 3Ms condition, parents will receive a brief (10-20 minute) computer delivered intervention at three consecutive routine diabetes clinic visits that is designed to increase parental motivation to supervise adolescent diabetes management. In the control condition, parents will receive computer-delivered education materials regarding type 1 diabetes. Data collection will be completed in the diabetes clinic at baseline and then at 6, 12 and 18 months after baseline in the families' home. Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life. Blood will also be collected to measure HbA1c (mean blood glucose level). Medical record data will also be collected. The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect model (LME) for repeated measures.

In addition to the clinical trial, 20 diabetes clinic staff members (5 at WSU from the CHM clinic; 15 from the Chicago clinics) will also be recruited to participate in qualitative interviews upon completion of the trial. The purpose of the interview is to identify barriers and facilitators of use of the 3Ms intervention at the level of the individual clinician, the diabetes clinic and the organization (hospital). Interviews will be audiotaped and subsequently transcribed for coding.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60612
        • Children's Hospital University of Illinois
      • Chicago, Illinois, United States, 60637
        • UChicago Medicine Comer Children's Hospital
      • Chicago, Illinois, United States, 60649
        • La Rabida Children's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Children's Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Educational Control
Participants in the standard educational control group will be provided with standard care regarding type 1 diabetes management during their routine clinic visits as usual. The standard care will be consistent with diabetes education provided by each of the study sites.
Experimental: The 3Ms Intervention + Standard Care
Parents will complete the first intervention session in the diabetes clinic immediately after baseline data collection and randomization. The subsequent two intervention sessions will also be conducted during regularly scheduled diabetes clinic visits.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic Control
Time Frame: Baseline, 6, 13 and 18 month follow-up
Hemoglobin A1c (HbA1c)
Baseline, 6, 13 and 18 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regimen Adherence (Objective)
Time Frame: Baseline, 6 months, 13 months, and 18 months
Glucose Meter (frequency of testing)
Baseline, 6 months, 13 months, and 18 months
Diabetes Management (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
Diabetes Management Scale (DMS)
Baseline, 6 months, 13 months, and 18 months
Parental Monitoring of Diabetes Care (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
The Parental Monitoring of Diabetes Care-Revised (PMDC-R)
Baseline, 6 months, 13 months, and 18 months
Diabetes- Specific Family Functioning (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
Diabetes Family Conflict Scale (DFCS-R)
Baseline, 6 months, 13 months, and 18 months
Adolescent Depression (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
Patient Reported Outcomes Measurement Information System (PROMIS)
Baseline, 6 months, 13 months, and 18 months
Executive Functioning (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
Behavior Rating Inventory of Executive Function (BRIEF)
Baseline, 6 months, 13 months, and 18 months
Cost Analysis (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
EuroQol five-dimensional (EQ-5D)
Baseline, 6 months, 13 months, and 18 months
Diabetes Emotional Distress (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
Problem Areas in Diabetes (PAID)
Baseline, 6 months, 13 months, and 18 months
Household Chaos (Self-reported)
Time Frame: Baseline, 6 months, 13 months, and 18 months
Confusion, Hubbub, and Order Scale (CHAOS)
Baseline, 6 months, 13 months, and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

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

Investigators

  • Principal Investigator: Deborah A Ellis, Ph.D., Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

August 3, 2021

Study Completion (Actual)

August 3, 2021

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015117B3E
  • R01DK110075 (U.S. NIH Grant/Contract)
  • 1R01DK110075-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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