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

Type 1 Diabetes Mellitus Clinical Trial

— 3Ms  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168867
• Other study ID #: 015117B3E
• Secondary ID: R01DK1100751R01D
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: August 3, 2021

Study information

• Verified date: April 2023
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Children's Hospital University of Illinois	Chicago	Illinois
United States	La Rabida Children's Hospital	Chicago	Illinois
United States	UChicago Medicine Comer Children's Hospital	Chicago	Illinois
United States	Ascension St. John Children's Hospital	Detroit	Michigan
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	William Beaumont Children's Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Hemoglobin A1c (HbA1c)	Baseline, 6, 13 and 18 month follow-up
Secondary	Regimen Adherence (Objective)	Glucose Meter (frequency of testing)	Baseline, 6 months, 13 months, and 18 months
Secondary	Diabetes Management (Self-reported)	Diabetes Management Scale (DMS)	Baseline, 6 months, 13 months, and 18 months
Secondary	Parental Monitoring of Diabetes Care (Self-reported)	The Parental Monitoring of Diabetes Care-Revised (PMDC-R)	Baseline, 6 months, 13 months, and 18 months
Secondary	Diabetes- Specific Family Functioning (Self-reported)	Diabetes Family Conflict Scale (DFCS-R)	Baseline, 6 months, 13 months, and 18 months
Secondary	Adolescent Depression (Self-reported)	Patient Reported Outcomes Measurement Information System (PROMIS)	Baseline, 6 months, 13 months, and 18 months
Secondary	Executive Functioning (Self-reported)	Behavior Rating Inventory of Executive Function (BRIEF)	Baseline, 6 months, 13 months, and 18 months
Secondary	Cost Analysis (Self-reported)	EuroQol five-dimensional (EQ-5D)	Baseline, 6 months, 13 months, and 18 months
Secondary	Diabetes Emotional Distress (Self-reported)	Problem Areas in Diabetes (PAID)	Baseline, 6 months, 13 months, and 18 months
Secondary	Household Chaos (Self-reported)	Confusion, Hubbub, and Order Scale (CHAOS)	Baseline, 6 months, 13 months, and 18 months