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Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199716
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE February 19, 2015
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
Daily frequency of blood glucose monitoring (BGM) [ Time Frame: up to 12 months ]
Number of glucose monitoring events per day
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
HbA1c levels [ Time Frame: up to 12 months ]
Values of HbA1c in blood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 23, 2017)
  • Diabetes knowledge [ Time Frame: up to 12 months ]
    Score measured by Diabetes Numeracy Test (DNT-15)
  • Degree of diabetes related family conflicts [ Time Frame: up to 12 months ]
    Score based on Questionnaire (r-DFCS)
  • Responsibility for diabetes care [ Time Frame: up to 12 months ]
    Score based on Diabetes Family Responsibility Questionnaire (DFRQ)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Official Title  ICMJE Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Brief Summary The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
Detailed Description The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. Diabetic knowledge, responsibility for diabetes care, degree of diabetes related family conflicts, and major complications of diabetes will also be collected during the patient's routine clinic visit. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE Other: Parent mentors
Parent mentors are to meet up with their assigned intervention group 4 times in 1 year and call the families monthly to document any diabetic complications
Study Arms  ICMJE
  • Experimental: Parent Mentors and Intervention Group
    Parent mentors are parents from our UC Davis Pediatrics Endocrinology clinic who have met our parent mentor inclusion criteria; the intervention group are families in our clinic who have met our mentee family inclusion criteria
    Intervention: Other: Parent mentors
  • No Intervention: Control Group with no Parent Mentors
    The control group is made up of families at our UC Davis Pediatrics Endocrinology clinic who have met the mentee family inclusion criteria but are not matched with a parent mentor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2019)
27
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2017)
66
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for mentee families:

  • Residing within 60 miles of a Parent Mentor
  • Child diagnosed with T1DM greater than or equal to 1 year at the start of our study's data collection (February 2015)
  • On multiple daily injection regime or insulin pump therapy
  • Mean HbA1c between 8.5 - 12.5% over the last 2 clinic visits

Inclusion Criteria for parent mentors:

  • Child diagnosed with T1DM greater than or equal to 2 years at the start of our study's data collection
  • Compliant with suggestions made by the diabetes care team
  • Mean HbA1c less than or equal to 8% over the last 2 clinic visits
  • No episodes of diabetic ketoacidosis, aside from initial episode at diagnosis, if applicable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03199716
Other Study ID Numbers  ICMJE 615897
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Children's Miracle Network
Investigators  ICMJE
Principal Investigator: Dennis Styne, MD UC Davis Pediatrics Endocrinology
Principal Investigator: Yvonne Lee, MD UC Davis Pediatrics Endocrinology
PRS Account University of California, Davis
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP