Clinical trial NCT03914547: Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
Official title: Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
name: University of Florida
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-04-16
Enrollment: 396
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators developed REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in Parents), an innovative video-based telemedicine intervention. In the pilot work, investigators found preliminary efficacy for REDCHiP in reducing parental FH, parenting stress, and children's HbA1c. The objective of this clinical trial 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 whether families who receive REDCHiP maintain reductions in FH, parenting stress, and child HbA1c at a 3-month followup compared to families who receive ATTN.

Detailed description: The purpose of this trial is to examine the efficacy of a real-time video-based telemedicine intervention addressing parental fear of hypoglycemia (FH) in families of young children with type 1 diabetes (T1D). Hypoglycemia is a common negative event associated with intensive insulin therapy in children with T1D. Young children with T1D are particularly vulnerable to episodes of hypoglycemia because they tend to be more insulin sensitive, may engage in unpredictable eating and physical activity patterns, and may be less able to recognize and report symptoms. 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 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, investigators 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 hypoglycemia avoidance behaviors. In the pilot work, investigators found preliminary efficacy for REDCHiP in reducing parental FH, parenting stress, and children's HbA1c. The objective of the proposed 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 whether families who receive REDCHiP maintain reductions in FH, parenting stress, and child HbA1c at a 3-month followup compared to families who receive ATTN. Investigators will recruit 180 families with the goal of retaining at least 144 through the 3-month followup. After informed consent, investigators 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. Primary outcomes of the revised trial are: parents' FH, parenting stress, children's HbA1c levels and children's glycemic variability (measured by percent time above, below and within-range). Secondary measures include child physical activity and sleep, parent sleep, parent depressive symptoms and anxiety, and parent psychopathology.

Eligibility criteria: Inclusion Criteria:

* Child age between 2-6.99 years
* Type 1 diabetes diagnosis ≥6 months
* Child is on an intensive insulin regimen (pump or multiple daily injection)

Exclusion Criteria:

* Parents of children on a conventional regimen
* Children who have an allergy or sensitivity to the adhesive and/or skin preparation used for continuous glucose monitoring
* Children with a comorbid chronic condition (e.g., renal disease)
* Parents who do not speak English.

Primary outcomes:
measure: Child Glycemic Control
timeFrame: change from baseline to post-treatment (week 14)
measure: Parents Hypoglycemia Fear
timeFrame: change from baseline to post-treatment (week 14)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
References:
citation: Patton SR, McConville A, Marker AM, Monzon AD, Driscoll KA, Clements MA. Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP): Protocol for a Randomized Clinical Trial to Test a Video-Based Telehealth Intervention. JMIR Res Protoc. 2020 Aug 18;9(8):e17877. doi: 10.2196/17877.