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Telemedicine Intervention for Type 1 Diabetes (REDCHiP Trial)

N/A

Waitlist Available

Led By Susana Patton, PhD, CDE

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child age between 2-6.99 years

Child age between 2-5.99 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to post-treatment (week 14)

Awards & highlights

REDCHiP Trial Summary

This trial is testing whether an innovative video-based telemedicine intervention (REDCHiP) can reduce parental stress and children's HbA1c (a measure of blood sugar).

Who is the study for?

This trial is for parents of young children aged 2-6.99 years with Type 1 diabetes on an intensive insulin regimen for at least 6 months. It excludes those whose children have other chronic conditions, are not on such a regimen, or have allergies to glucose monitoring adhesives.Check my eligibility

What is being tested?

The study tests REDCHiP, a video-based telemedicine intervention aimed at reducing parental fear of hypoglycemia and stress, against ATTN (an attention control). It measures the impact on parents' stress levels and children's HbA1c both after treatment and at a 3-month follow-up.See study design

What are the potential side effects?

As this trial involves behavioral interventions through telemedicine rather than medication or invasive procedures, there are no direct medical side effects associated with REDCHiP or ATTN.

REDCHiP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 2 and almost 7 years old.

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My child is between 2 and 6 years old.

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My child uses an insulin pump or gets several insulin shots daily.

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I have been diagnosed with Type 1 diabetes for at least 6 months.

REDCHiP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to post-treatment (week 14)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to post-treatment (week 14)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-treatment (week 14) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child Glycemic Control

Parents Hypoglycemia Fear

REDCHiP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: REDCHiP intervention armExperimental Treatment1 Intervention

REDCHiP uses 10- video-based telemedicine sessions to deliver T1D education, behavioral parent training, and problem-solving to enhance parents' knowledge and skills. Sessions last about 45-60 minutes each.

Group II: Attention Control armActive Control1 Intervention

ATTN uses 10- video-based telemedicine sessions to deliver general patient education specific to young children. Similar to REDCHiP, all ATTN sessions last 45-60 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

REDCHiP

2015

N/A

~50

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

17,735 Total Patients Enrolled

Children's Mercy Hospital Kansas CityOTHER

245 Previous Clinical Trials

935,490 Total Patients Enrolled

University of Kansas Medical CenterLead Sponsor

460 Previous Clinical Trials

168,719 Total Patients Enrolled

Media Library

REDCHiP Clinical Trial Eligibility Overview. Trial Name: NCT03914547 — N/A

Type 1 Diabetes Research Study Groups: REDCHiP intervention arm, Attention Control arm

Type 1 Diabetes Clinical Trial 2023: REDCHiP Highlights & Side Effects. Trial Name: NCT03914547 — N/A

REDCHiP 2023 Treatment Timeline for Medical Study. Trial Name: NCT03914547 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this trial eighteen or older?

"This medical trial is enrolling young patients between the ages of two and six."

Answered by AI

How many individuals have signed up to participate in this research endeavor?

"Yes, the current information on clinicaltrials.gov indicates that this ongoing study is actively looking for volunteers. It was first published in October 2019 and recently updated in May 2022. The total participant pool required to complete this trial is 360 persons between 3 different locations."

Answered by AI

How can I become a participant in this medical experiment?

"This experiment is looking for 360 participants between the ages of 2 and 6 with Type 1 diabetes. The prospective patients must have been diagnosed at least six months prior to enrollement, be on an intensive insulin regimen (pump or multiple daily injections), and meet all other criteria outlined in the study's information packet."

Answered by AI

Are there available spots for volunteers to join this experiment?

"The information presented on clinicaltrials.gov suggests that this research effort is actively searching for participants with the initial posting taking place on October 15th 2019 and most recent update having occurred May 16th 2022."

Answered by AI