Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent mentors
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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
Sites / Locations
- UC Davis Pediatrics Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parent Mentors and Intervention Group
Control Group with no Parent Mentors
Arm Description
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
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
Outcomes
Primary Outcome Measures
Daily frequency of blood glucose monitoring (BGM)
Number of glucose monitoring events per day
Secondary Outcome Measures
HbA1c levels
Values of HbA1c in blood
Full Information
NCT ID
NCT03199716
First Posted
February 19, 2015
Last Updated
June 10, 2019
Sponsor
University of California, Davis
Collaborators
Children's Miracle Network
1. Study Identification
Unique Protocol Identification Number
NCT03199716
Brief Title
Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Official Title
Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Children's Miracle Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent Mentors and Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group with no Parent Mentors
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Parent mentors
Intervention Description
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
Primary Outcome Measure Information:
Title
Daily frequency of blood glucose monitoring (BGM)
Description
Number of glucose monitoring events per day
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
HbA1c levels
Description
Values of HbA1c in blood
Time Frame
up to 12 months
Other Pre-specified Outcome Measures:
Title
Diabetes knowledge
Description
Score measured by Diabetes Numeracy Test (DNT-15)
Time Frame
up to 12 months
Title
Degree of diabetes related family conflicts
Description
Score based on Questionnaire (r-DFCS)
Time Frame
up to 12 months
Title
Responsibility for diabetes care
Description
Score based on Diabetes Family Responsibility Questionnaire (DFRQ)
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Styne, MD
Organizational Affiliation
UC Davis Pediatrics Endocrinology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yvonne Lee, MD
Organizational Affiliation
UC Davis Pediatrics Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Pediatrics Endocrinology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
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