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

NCT ID: NCT03199716

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-03-23

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Parent mentors

Intervention Type: OTHER

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

Sponsors

Children's Miracle Network

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Styne, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis Pediatrics Endocrinology

Yvonne Lee, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis Pediatrics Endocrinology

Locations

UC Davis Pediatrics Endocrinology

Sacramento, California, United States

Countries

United States

Other Identifiers

615897

Identifier Type: -

Identifier Source: org_study_id