Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): The 3Ms Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin dependent diabetes mellitus; adolescents/young adults; e-health intervention; parental monitoring