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Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children (REDCHiP)

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ClinicalTrials.gov Identifier: NCT03914547
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 6, 2020
Sponsor:
Collaborators:
Children's Mercy Hospital Kansas City
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: REDCHiP Behavioral: ATTN Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: REDCHiP
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.
Behavioral: REDCHiP
REDCHiP includes seven group-based sessions and three individual sessions. REDCHiP uses a three-pronged approach to reduce parents' FH. It uses T1D education and problem-solving to enhance parents' knowledge and skills. It uses child age-appropriate behavioral parent training to promote parents' skills and confidence in managing disruptive child behaviors and reducing their reliance on hypoglycemia avoidance behaviors. It uses cognitive-behavioral therapy strategies to help parents reduce maladaptive thinking/coping related to hypoglycemia fear.

Active Comparator: ATTN
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.
Behavioral: ATTN
Provides a similar attention control. ATTN includes seven group-based sessions and three individual sessions.




Primary Outcome Measures :
  1. Child Glycemic Control [ Time Frame: change from baseline to post-treatment (week 14) ]
    Child glycemic control will be measured by change in hemoglobin A1c (HbA1c) NGSP (%) between baseline and post-treatment.

  2. Parents Hypoglycemia Fear [ Time Frame: change from baseline to post-treatment (week 14) ]
    Parental fear will be measured by the Hypoglycemia Fear Survey - Parents of Young Children (HFS-PYC), a 26-item survey with a score range of 26-130. Higher scores indicate a higher fear rating.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child age between 2-5.99 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914547


Contacts
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Contact: Susana R Patton, PhD, CDE 904-697-3595 susana.patton@nemours.org
Contact: Andrew McConville, BA ammcconville@cmh.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Kimberly Driscoll, PhD       k.driscoll@phhp.ufl.edu   
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Susana Patton, PhD, CDE         
United States, Missouri
The Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Mark Clements, MD PhD       maclements@cmh.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Children's Mercy Hospital Kansas City
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Susana Patton, PhD, CDE susana.patton@nemours.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03914547    
Other Study ID Numbers: STUDY00000545
1R01DK118514-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share individual participant data; de-identified group data may be available to qualified researchers upon request to the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases