Dataset Information

Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP).

ABSTRACT:

Objective

To evaluate the efficacy of a new video-based telehealth intervention to reduce hypoglycemia fear in parents of young children with type 1 diabetes.

Methods

We randomized 42 parents to either immediate treatment (reducing emotional distress for childhood hypoglycemia in parents, REDCHiP; n = 22) or a waitlist control (WAITLIST; n = 21) condition. REDCHiP parents completed a 10-session video-based telehealth intervention, while WAITLIST parents continued in usual care. After 14-weeks, WAITLIST parents completed the telehealth treatment. We examined for between group changes in parental hypoglycemia fear and parenting stress (n = 18 per condition), 3-month maintenance of treatment effects for parents randomized to REDCHiP (n = 15), and pre-post changes for the entire sample (n = 36).

Results

Mostly mothers participated (97.6%). They reported a mean age of 35.2 ±?5.0?years at pre-treatment. Children were 4.4 ±?1.4?years old and 59.5% boys. Between group comparisons showed a significant reduction in hypoglycemia fear (P =?.04) and a trend toward reduction in parenting stress-frequency (P =?.092) for REDCHiP parents compared to WAITLIST parents. After the three-month maintenance period, REDCHiP parents reported significant reductions in hypoglycemia fear, parenting stress-frequency, and parenting stress-difficulty (P's ConclusionOur new video-based telehealth intervention appears to reduce hypoglycemia fear and parenting stress and may help parents of very young children with T1D to better achieve optimal child glycemic control when children are above target.

SUBMITTER: Patton SR

PROVIDER: S-EPMC7393613 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP).

Patton Susana R SR Clements Mark A MA Marker Arwen M AM Nelson Eve-Lynn EL

Pediatric diabetes 20191103 1

<h4>Objective</h4>To evaluate the efficacy of a new video-based telehealth intervention to reduce hypoglycemia fear in parents of young children with type 1 diabetes.<h4>Methods</h4>We randomized 42 parents to either immediate treatment (reducing emotional distress for childhood hypoglycemia in parents, REDCHiP; n = 22) or a waitlist control (WAITLIST; n = 21) condition. REDCHiP parents completed a 10-session video-based telehealth intervention, while WAITLIST parents continued in usual care. Af ...[more]

PMID: 31610073

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Project description:BACKGROUND:Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children. OBJECTIVE:The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention. METHODS:We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children. RESULTS:Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date. CONCLUSIONS:If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world. TRIAL REGISTRATION:ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/17877.

Project description:BACKGROUND:In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings). METHODS/DESIGN:A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. DISCUSSION:Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. TRIAL REGISTRATION:ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018.

Project description:IntroductionIt is crucial to understand psychosocial outcomes in children and adolescents with type 1 diabetes (T1D) and their families to provide optimal family-centered care. Hence, the aim of this study was to explore psychosocial outcomes in young people with T1D and their parents using currently available glucose monitoring devices in a real-life clinic setting.MethodsChildren and adolescents aged 2-18 years with T1D for more than 6 months and their parents were recruited into a cross-sectional study to complete the Hypoglycemia Fear Survey (HFS) and the Pediatric Quality of Life Inventory (PedsQL) Generic Score Scales, Diabetes Module and Family Impact Module. Demographics and diabetes-specific parameters were obtained from medicals records.ResultsFifty-nine children and adolescents (mean age 15.1 ± 3.0 years) and 49 parents of children (mean age of children 12.5± 3.3 years) of which 44 were child-parent dyads completed the questionnaires. Parents had a higher mean (SD) FOH total and worry subscore than children, total score was 37.9 (14.6) vs. 32.2 (11.9), p = 0.047 and worry subscore was 17.8 (10.4) vs. 12.8 (9.0), p = 0.01. Furthermore, lower parental diabetes-specific QoL score was observed in parents, 78.8 (12.2) vs. 82.7 (10.3), p=0.02. No difference in FOH and QoL between real-time continuous glucose monitoring (rtCGM) and intermittently scanned glucose monitoring (isCGM) users and users of devices with and without alerts was observed. In isCGM users (n=36 completing the child questionnaires, n=33 completing parent questionnaires), higher parental FOH and lower parental diabetes-specific QoL correlated with higher scanning frequency, r = 0.399, p = 0.021, and r = -0.464, p = 0.007 respectively. No significant correlation was documented between scanning frequency and child questionnaire scores.ConclusionsParents are more likely to perceive higher levels of psychosocial burden related to their child's diabetes than children and adolescents with T1D, especially parents of younger children. This highlights the need for family-based education and treatment resources to support parents in diabetes management in addition to rapidly advancing diabetes technology. In isCGM users, higher parental FOH and lower parent-perceived QoL correlated with a higher scanning frequency, indicating the potential impact of glucose monitoring modality on psychosocial outcomes or vice versa.

Dataset Information

Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP).

Objective

Methods

Results

Publications

Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP).

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