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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: The 3Ms Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Educational Control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parental monitoring, insulin dependent diabetes mellitus, adolescents/young adults, e-health intervention