NCT03879642

Brief Summary

Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 14, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

March 11, 2019

Results QC Date

October 14, 2021

Last Update Submit

January 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia Fear Survey

    Hypoglycemia Fear Survey-Parents of Young Children. This is a measure of parents' perceived hypoglycemia fear. Higher scores suggest greater fear (worse outcome). Total possible range: 26-130.

    absolute value at post-treatment (week 14)

Secondary Outcomes (1)

  • Child Hemoglobin A1c

    absolute value at post-treatment (week 14)

Study Arms (2)

REDCHiP

EXPERIMENTAL

10 week video-based telemedicine intervention to reduce parents hypoglycemia fear

Behavioral: REDCHiP

Waitlist

NO INTERVENTION

10 week no intervention to provide waitlist control condition

Interventions

REDCHiPBEHAVIORAL

10 week video-based telemedicine intervention to reduce hypoglycemia fear

REDCHiP

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents of children, between 1-6 years old, with type 1 diabetes for at least 6 months, on either multiple daily injections or an insulin pump, and parents speak English

You may not qualify if:

  • Families of children who are older than 6 years-old and or do not have type 1 diabetes; children follow a conventional insulin regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Patton SR, Monzon AD, Noser AE, Clements MA. Physical Activity, Glycemic Variability, and Parental Hypoglycemia Fear in Preschoolers With Type 1 Diabetes. Pediatr Exerc Sci. 2022 Jan 19;34(3):135-140. doi: 10.1123/pes.2021-0046. Print 2022 Aug 1.

  • Patton SR, Clements MA, Marker AM, Nelson EL. Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP). Pediatr Diabetes. 2020 Feb;21(1):112-119. doi: 10.1111/pedi.12934. Epub 2019 Nov 3.

  • Marker AM, Monzon AD, Nelson EL, Clements MA, Patton SR. An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability. Diabetes Technol Ther. 2020 Jan;22(1):25-33. doi: 10.1089/dia.2019.0244. Epub 2019 Nov 13.

Results Point of Contact

Title
Dr. Susana Patton
Organization
Nemours Children's Health-Jacksonville

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized control pilot using a waitlist control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 19, 2019

Study Start

October 1, 2015

Primary Completion

October 1, 2018

Study Completion

March 1, 2019

Last Updated

January 25, 2022

Results First Posted

January 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share