Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Behavioral: The 3Ms Intervention
- Registration Number
- NCT03168867
- Lead Sponsor
- Wayne State University
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The 3Ms Intervention + Standard Care The 3Ms Intervention 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.
- Primary Outcome Measures
Name Time Method Glycemic Control Baseline, 6, 13 and 18 month follow-up Hemoglobin A1c (HbA1c)
- Secondary Outcome Measures
Name Time Method Regimen Adherence (Objective) Baseline, 6 months, 13 months, and 18 months Glucose Meter (frequency of testing)
Diabetes Management (Self-reported) Baseline, 6 months, 13 months, and 18 months Diabetes Management Scale (DMS)
Parental Monitoring of Diabetes Care (Self-reported) Baseline, 6 months, 13 months, and 18 months The Parental Monitoring of Diabetes Care-Revised (PMDC-R)
Diabetes- Specific Family Functioning (Self-reported) Baseline, 6 months, 13 months, and 18 months Diabetes Family Conflict Scale (DFCS-R)
Executive Functioning (Self-reported) Baseline, 6 months, 13 months, and 18 months Behavior Rating Inventory of Executive Function (BRIEF)
Household Chaos (Self-reported) Baseline, 6 months, 13 months, and 18 months Confusion, Hubbub, and Order Scale (CHAOS)
Adolescent Depression (Self-reported) Baseline, 6 months, 13 months, and 18 months Patient Reported Outcomes Measurement Information System (PROMIS)
Cost Analysis (Self-reported) Baseline, 6 months, 13 months, and 18 months EuroQol five-dimensional (EQ-5D)
Diabetes Emotional Distress (Self-reported) Baseline, 6 months, 13 months, and 18 months Problem Areas in Diabetes (PAID)
Trial Locations
- Locations (7)
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
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
La Rabida Children's Hospital
🇺🇸Chicago, Illinois, United States
William Beaumont Children's Hospital
🇺🇸Royal Oak, Michigan, United States
Ascension St. John Children's Hospital
🇺🇸Detroit, Michigan, United States