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

• ClinicalTrials.gov Identifier: NCT03879642
• Recruitment Status: Completed
• First Posted: March 19, 2019
• Results First Posted: January 14, 2022
• Last Update Posted: January 25, 2022
• Sponsor: University of Kansas Medical Center
• Collaborator: Children's Mercy Hospital Kansas City
• Information provided by (Responsible Party): University of Kansas Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Parents
• Intervention: Behavioral: REDCHiP
• Enrollment: 43

Participant Flow

Recruitment Details	recruitment in clinic and by telephone
Pre-assignment Details	the study over-recruited the original study protocol by 3 parents; pre-assignment, parents completed baseline assessment measures;

Arm/Group Title	REDCHiP	Waitlist
Arm/Group Description	10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear	10 week no intervention to provide waitlist control condition
Period Title: Overall Study
Started	22	21
Completed	19	18
Not Completed	3	3

Baseline Characteristics

Arm/Group Title		REDCHiP	Waitlist	Total
Arm/Group Description		10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear	10 week no intervention to provide waitlist control condition	Total of all reporting groups
Overall Number of Baseline Participants		22	21	43
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	21 participants	43 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	22 100.0%	21 100.0%	43 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	21 participants	20 participants	41 participants
		33.81 (4.59)	36.75 (5.02)	36.0 (4.9)
		[1] Measure Analysis Population Description: one parent from each condition did not complete all the baseline assessment measures
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	20 participants	41 participants
	Female	21 100.0%	19 95.0%	40 97.6%
	Male	0 0.0%	1 5.0%	1 2.4%
		[1] Measure Analysis Population Description: one parent from each condition did not complete all baseline assessments
Ethnicity (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	20 participants	42 participants
	Hispanic or Latino	1 4.5%	1 5.0%	2 4.8%
	Not Hispanic or Latino	21 95.5%	17 85.0%	38 90.5%
	Unknown or Not Reported	0 0.0%	2 10.0%	2 4.8%
		[1] Measure Analysis Population Description: one parent in the waitlist control group did not complete this survey
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	21 participants	43 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	1 4.8%	1 2.3%
	White	21 95.5%	19 90.5%	40 93.0%
	More than one race	1 4.5%	0 0.0%	1 2.3%
	Unknown or Not Reported	0 0.0%	1 4.8%	1 2.3%

Outcome Measures

1. Primary Outcome

Title	Hypoglycemia Fear Survey
Description	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.
Time Frame	absolute value at post-treatment (week 14)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	REDCHiP	Waitlist
Arm/Group Description:	10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear	10 week no intervention to provide waitlist control condition
Overall Number of Participants Analyzed	18	18
Mean (Standard Deviation); Unit of Measure: units on a scale
	75.94 (18.46)	70.78 (14.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REDCHiP, Waitlist
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	partial eta squared
	Estimated Value	.117
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Child Hemoglobin A1c
Description	Child hemoglobin A1c- biological marker of glycemic control
Time Frame	absolute value at post-treatment (week 14)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	REDCHiP	Waitlist
Arm/Group Description:	10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear	10 week no intervention to provide waitlist control condition
Overall Number of Participants Analyzed	18	18
Mean (Standard Deviation); Unit of Measure: percentage of glycated hemoglobin cells
	8.07 (1.30)	7.97 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REDCHiP, Waitlist
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	repeated measures ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	partial eta squared
	Estimated Value	.005
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	through study completion, average 7 months
Adverse Event Reporting Description	Adverse event = episodes of prolong low blood glucose value (>1 hour); increase in frequency of any low blood glucose events (glucose <70 mg/dl)
Arm/Group Title	REDCHiP	Waitlist
Arm/Group Description	10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear	10 week no intervention to provide waitlist control condition
All-Cause Mortality
	REDCHiP	Waitlist
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	0/21 (0.00%)
Serious Adverse Events
	REDCHiP	Waitlist
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	0/21 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	REDCHiP	Waitlist
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	0/21 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Susana Patton
• Organization: Nemours Children's Health-Jacksonville
• Phone: 904-697-2000
• EMail: susana.patton@nemours.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03879642
• Other Study ID Numbers: R21HD081502 ( U.S. NIH Grant/Contract )
• First Submitted: March 11, 2019
• First Posted: March 19, 2019
• Results First Submitted: October 14, 2021
• Results First Posted: January 14, 2022
• Last Update Posted: January 25, 2022