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

NCT ID: NCT03168867

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2021-08-03

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard Educational Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

The 3Ms Intervention + Standard Care

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.

Group Type: EXPERIMENTAL

The 3Ms Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Deborah Ellis, Ph.D.

Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah A Ellis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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

La Rabida Children's Hospital

Chicago, Illinois, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Ascension St. John Children's Hospital

Detroit, Michigan, United States

William Beaumont Children's Hospital

Royal Oak, Michigan, United States

Countries

United States

References

Knauft KM, Jacques-Tiura AJ, Carcone AI, Evans MA, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB, Ellis D. Blood Glucose Levels and Diabetes Family Conflict in Black Adolescents with Type 1 Diabetes During the COVID-19 Pandemic. Behav Med. 2025 Aug 27:1-15. doi: 10.1080/08964289.2025.2543265. Online ahead of print.

Reference Type: DERIVED

PMID: 40859913 (View on PubMed)

Knauft KM, Jacques-Tiura AJ, Idalski Carcone A, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab B, Ellis DA. The moderating role of diabetes distress on the effect of a randomized eHealth intervention on glycemic control in Black adolescents with type 1 diabetes. J Pediatr Psychol. 2024 Aug 1;49(8):538-546. doi: 10.1093/jpepsy/jsae033.

Reference Type: DERIVED

PMID: 38775162 (View on PubMed)

Ellis D, Carcone AI, Templin T, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB. Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial. JMIR Diabetes. 2024 Apr 9;9:e55165. doi: 10.2196/55165.

Reference Type: DERIVED

PMID: 38593428 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK110075

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01DK110075-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

015117B3E

Identifier Type: -

Identifier Source: org_study_id