Clinical trial NCT03168867: Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
Official title: Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: insulin dependent diabetes mellitus
adolescents/young adults
e-health intervention
parental monitoring
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-05-30
Enrollment: 149
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic Control
timeFrame: Baseline, 6, 13 and 18 month follow-up
Secondary outcomes:
measure: Regimen Adherence (Objective)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Diabetes Management (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Parental Monitoring of Diabetes Care (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Diabetes- Specific Family Functioning (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Adolescent Depression (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Executive Functioning (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Cost Analysis (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Diabetes Emotional Distress (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
measure: Household Chaos (Self-reported)
timeFrame: Baseline, 6 months, 13 months, and 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Children's Hospital University of Illinois
state: Illinois
city: Chicago
country: United States
facility: UChicago Medicine Comer Children's Hospital
state: Illinois
city: Chicago
country: United States
facility: La Rabida Children's Hospital
state: Illinois
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Children's Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Children's Hospital
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deborah A Ellis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: