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

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ClinicalTrials.gov Identifier: NCT03168867
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Deborah Ellis, Ph.D., 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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: The 3Ms Intervention Not Applicable

Detailed Description:

The study will be conducted at one clinic in the Detroit area (Children's Hospital of Michigan; CHM) and 3 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/CHM and half at the three 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
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.




Primary Outcome Measures :
  1. Metabolic Control [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Hemoglobin A1c (HbA1c)


Secondary Outcome Measures :
  1. Regimen Adherence (objective) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Glucose Meter (frequency of testing)

  2. Diabetes Management (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Diabetes Management Scale (DMS)

  3. Parental Monitoring of Diabetes Care (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    The Parental Monitoring of Diabetes Care-Revised (PMDC-R)

  4. Diabetes- Specific Family Functioning (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Diabetes Family Conflict Scale (DFCS-R)

  5. Adolescent Depression (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Patient Reported Outcomes Measurement Information System (PROMIS)

  6. Executive Functioning (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Behavior Rating Inventory of Executive Function (BRIEF)

  7. Cost Analysis (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    EuroQol five-dimensional (EQ-5D)

  8. Diabetes Emotional Distress (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Problem Areas in Diabetes (PAID)

  9. Household Chaos (self-reported) [ Time Frame: Change from Baseline at 6 months, 13 months, and 18 months ]
    Confusion, Hubbub, and Order Scale (CHAOS)



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168867


Contacts
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Contact: Jillian T Rhind, B.S. 313-577-6997 jrhind@med.wayne.edu

Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Meredyth Evans, Ph.D.    312-227-3441    MAEvans@luriechildrens.org   
Principal Investigator: Jill Weissberg-Benchell, Ph.D.         
Children's Hospital University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Meredyth Evans, Ph.D.    312-227-3441    MAEvans@luriechildrens.org   
Principal Investigator: Jill Weissberg-Benchell, Ph.D.         
La Rabida Children's Hospital Recruiting
Chicago, Illinois, United States, 60649
Contact: Meredyth Evans, Ph.D.    312-227-3441    MAEvans@luriechildrens.org   
Principal Investigator: Jill Weissberg-Benchell, Ph.D.         
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Jillian Rhind    313-577-6997    jrhind@med.wayne.edu   
Principal Investigator: Deborah A Ellis, Ph.D.         
Sponsors and Collaborators
Wayne State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Deborah A Ellis, Ph.D. Wayne State University

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Responsible Party: Deborah Ellis, Ph.D., Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine, Wayne State University
ClinicalTrials.gov Identifier: NCT03168867     History of Changes
Other Study ID Numbers: 015117B3E
R01DK110075 ( U.S. NIH Grant/Contract )
1R01DK110075-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deborah Ellis, Ph.D., Wayne State University:
insulin dependent diabetes mellitus
adolescents/young adults
e-health intervention
parental monitoring

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases