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Home Video-Based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children

Award Number: R01DK118514
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT Young children with type 1 diabetes (T1D) remain highly vulnerable to episodes of hypoglycemia despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitors (CGM). Parents and young children living with T1D quickly learn to fear hypoglycemia because it is uncomfortable, embarrassing, seemingly unpredictable, and potentially dangerous. Indeed, research shows that parents of young children report high rates of moderate to severe hypoglycemia fear (FH). Unfortunately, FH leads to two problems: impaired quality of life and compensatory behaviors that raise children’s blood glucose levels leading to on-going poor metabolic control (HbA1c) and an increased risk for long-term vascular complications. Responding to a critical need for interventions to treat parental FH in families of young children, we developed an innovative video-based telemedicine intervention, called REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in Parents). REDCHiP uses cognitive behavioral therapy, T1D education, and behavioral parent training in a 10- session individual and group-based telemedicine program, to reduce parental FH and to teach parents how to change hypoglycemic avoidance behaviors. In our pilot work, we found preliminary efficacy for REDCHiP in reducing parental FH, parenting stress, and children’s HbA1c. The objective of this R01 is to conduct a randomized clinical trial (RCT) comparing REDCHiP to a relevant attention control intervention (ATTN) in families of young children, thereby continuing to establish its efficacy. The proposed R01 aims are: 1) To evaluate whether parents who receive REDCHiP report reductions in FH and parenting stress at post-treatment compared to parents who receive the ATTN; 2) To evaluate whether children of parents who receive REDCHiP have a lower HbA1c and less glycemic variability at post-treatment compared to children of parents who receive ATTN; 3) To examine for maintenance of improvements in FH, parenting stress, and children’s HbA1c in a 3-month followup. We will recruit 180 families with the goal of retaining at least 144 through the 3-month followup. After informed consent, we will randomize parents to either REDCHiP or ATTN and have them complete baseline measures (e.g., parent surveys, child glucose sensing, child/parent accelerometry, and child HbA1c). Then, parents in both groups will participate in 10 video-based telemedicine sessions matched for time and format (group v individual). At post-treatment, parents and children will repeat the baseline assessment; at the 3-month followup, parents will complete surveys and children will undergo glucose sensing and an HbA1c. The impact of the proposed R01 is high because parental FH is common and relates to poor T1D self-care and child glycemic control, which can lead to expensive and dangerous present and future complications. It is Innovative because of its use of video- and group-based telemedicine which is responsive to NIDDK initiatives as well as potentially scalable to even smaller T1D centers. Efficacy testing REDCHiP in a larger RCT is the logical next step in our research program and likely to yield an effective and scalable treatment that can improve children’s health.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $546,251 )
2024	2024	THE NEMOURS FOUNDATION	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	3/29/2024	NON-COMPETING CONTINUATION	$512,111
2024	2024	THE NEMOURS FOUNDATION	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	5/21/2024	NON-COMPETING CONTINUATION	$34,140
														Subtotal = $546,251

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/6/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $574,456 )
2022	2022	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/30/2022	NON-COMPETING CONTINUATION	$574,456
														Subtotal = $574,456

Issue Date FY: 2021 ( Subtotal = $596,332 )
2021	2021	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	4/1/2021	NON-COMPETING CONTINUATION	$596,332
														Subtotal = $596,332

Issue Date FY: 2020 ( Subtotal = $594,344 )
2020	2020	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	3	4/23/2020	NON-COMPETING CONTINUATION	$46,246
2020	2020	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	4/9/2020	NON-COMPETING CONTINUATION	$602,837
2020	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	1	4/23/2020	NEW	-$46,246
2020	2019	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	3/2/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$580,753
2020	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/2/2020	NEW	-$589,246
														Subtotal = $594,344

Issue Date FY: 2019 ( Subtotal = $667,862 )
2019	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/27/2019	NEW	$667,862
														Subtotal = $667,862

Grand Total All Awards = $2,979,245

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Home Video-Based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children

Award Number: R01DK118514

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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