ParentsREDCHiPNCT03879642

Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes

A study testing REDCHiP in people with Parents, run by University of Kansas Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 1 year to 6 years
Conditions the study is for: Parents
What is being tested?: REDCHiP
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: No sites listed yet
Study dates: 1 Oct 2015to Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

About this study

Official title: Reducing Hypoglycemia Fear in Parents of Young Kids Via Video-based Telemedicine

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

Read the detailed description

This was a two group randomized controlled study using a wait-list control design. All participating parents had the opportunity to receive 10 video-based telemedicine sessions administered over 13 weeks. Study assessments took place at baseline, post-treatment, and 3 month followup. Study outcomes included parent reported hypoglycemia fear, parenting stress, diabetes distress, and child glycated hemoglobin.

Conditions: Parents
Being tested: REDCHiP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03879642
Study group	Role	What they receive
REDCHiP	Experimental	10 week video-based telemedicine intervention to reduce parents hypoglycemia fear Receives: Behavioral: REDCHiP
Waitlist	No intervention	10 week no intervention to provide waitlist control condition

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: absolute value at post-treatment (week 14)

Secondary outcomes (1)

Child Hemoglobin A1c
Child hemoglobin A1c- biological marker of glycemic control
Measured: absolute value at post-treatment (week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 2015Mar 2019

First posted19 Mar 2019
Study start1 Oct 2015
Primary completion1 Oct 2018
Study completionMar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ParentsStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized control pilot using a waitlist control group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03879642
Sponsor's protocol ID: R21HD081502
Acronym: REDCHiP
Status last verified: Jan 2022
First submitted: 11 Mar 2019
Last updated: 25 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35045389
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.
PubMed 31610073
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.
PubMed 31517512

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Parents trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Hypoglycemia Fear in Parents of Young Kids Via Video-based Telemedicine
ClinicalTrials.gov ID: NCT03879642
Acronym / sponsor ID: REDCHiP / R21HD081502
Conditions: Parents
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: Children's Mercy Hospital Kansas City
Study start: 1 Oct 2015 (actual)
Primary completion: 1 Oct 2018 (actual)
Study completion: Mar 2019 (actual)
First posted: 19 Mar 2019 (actual)
Results: Posted 14 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: randomized control pilot using a waitlist control group

Arm	Type	Receives
REDCHiP	Experimental	Behavioral: REDCHiP10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
Waitlist	No intervention	–10 week no intervention to provide waitlist control condition

Who may qualify

Ages: 1 year to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REDCHiP10 week video-based telemedicine intervention to reduce hypoglycemia fear	Behavioural	REDCHiP

Primary outcome

Hypoglycemia Fear Survey
Time frame: absolute value at post-treatment (week 14)
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.

1 secondary outcome

Child Hemoglobin A1c
Time frame: absolute value at post-treatment (week 14)

Results and safety

Results posted to the registry on 14 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
REDCHiP	22	19
Waitlist	21	18

Primary outcome: Hypoglycemia Fear Survey

Time frame: absolute value at post-treatment (week 14). Mean (Standard Deviation). Unit: units on a scale

Measure	REDCHiP n = 18	Waitlist n = 18
Value	75.94 (18.46)	70.78 (14.93)

REDCHiP vs Waitlist: partial eta squared: .117, ANOVA

Population analysed: 43 parents enrolled and were randomized; 36 parents completed the treatment. Therefore number analyzed reflects 36 parents who completed treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: through study completion, average 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
REDCHiP	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Waitlist	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35045389Patton 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.
Derived from this study: PubMed 31610073Patton 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.
Derived from this study: PubMed 31517512Marker 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing REDCHiP in people with Parents, run by University of Kansas Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypoglycemia Fear Survey (time frame: absolute value at post-treatment (week 14)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879642, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.