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Try out PMC Labs and tell us what you think. Learn More. Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring CGMyoung 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. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
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. 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 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 years or yearschild 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.
Recruitment began in Julyand enrollment is ongoing. The first wave of intervention delivery began in December We anticipate completing enrollment in Final reporting of will occur within 12 months of the primary completion date. 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.
Type 1 diabetes mellitus T1D is a common pediatric chronic condition characterized by the loss of natural insulin production and inability to regulate blood glucose levels. Incidence rates of T1D are increasing in children aged younger than 6 years internationally [ 1 ], and data also demonstrate a 1.
Managing T1D is particularly challenging in young children because of their heightened insulin sensitivity, unpredictable eating behaviors, inconsistent physical activity levels, and limited communication skills [ 5 ], which lead to extreme glycemic variations and severe hypoglycemic episodes [ 6 ]. Hypoglycemia events, or low blood glucose levels, are an immediate and dangerous complication of T1D [ 7 ]. Symptoms of hypoglycemia may include headaches, dizziness, impaired consciousness, irritability, weakness, sweating, racing pulse, and, in extreme cases, seizure, coma, or death [ 89 ].
Prevalence rates for severe hypoglycemia in young children with T1D are 2-fold higher than older children and adolescents and 3-fold higher than adults [ 10 ]. Not surprisingly, it is common for caregivers of young children with T1D to report elevated stress and anxiety regarding the probability of their child experiencing a hypoglycemia event [ 11 ]. Unfortunately, the introduction of new technologies such as shorter and longer acting insulin analogs, insulin pumps, and continuous glucose monitors CGMs have not eliminated the occurrence of hypoglycemia events in young children [ 11 - 13 ] or reduced caregiver fear of hypoglycemia [ 1114 ].
Additionally, Looking for cam sex of Harrington and hypoglycemic young children with T1D, caregivers may perceive hypoglycemia as unpredictable, exacerbating their level of fear [ 16 ]. Building on past research, we developed a theoretical model for caregiver fear of hypoglycemia Figure 1 which identifies child and caregiver variables that may underlie caregiver fear of hypoglycemia. In addition, in older youth with T1D, there is evidence that child physical activity levels relate to caregiver fear of hypoglycemia [ 19 - 22 ]. For caregiver variables, several studies suggest that T1D-related distress, parenting stress, caregiver depressive and anxiety symptoms, and decreased caregiver sleep may exacerbate their perceptions of fear of hypoglycemia [ 23 - 27 ].
Our theoretical model of caregiver fear of hypoglycemia then proposes that greater caregiver fear of hypoglycemia relates to hypoglycemia avoidance behaviors, including maintaining blood glucose levels above the recommended range, treating blood glucose levels that are within the target range, and delaying or reducing insulin doses [ 1628 ]. Our theoretical model of caregiver fear of hypoglycemia suggests that when caregivers engage in more hypoglycemia avoidance behaviors, these maladaptive coping strategies lead to chronically higher blood glucose levels, more glycemic variability, and increased risk for T1D-related complications for children [ 2930 ].
Thus, our model suggests that caregiver fear of hypoglycemia may function as a barrier to optimal glycemic control and should be a target of behavioral interventions for families of young children with T1D. In-person clinic visits have been a mainstay of behavioral interventions for families of youth with T1D, but this approach also presents logistical barriers eg, travel, time, and cost.
For this reason, the use of technology-based delivery methods has increased both in research and clinical settings. Access to mobile technology and the internet is ubiquitous in the United States. To date, most technology-based T1D interventions have focused on T1D management in adolescents and young adults versus families of young children, and the interventions have used and text message support [ 33 - 35 ], websites and phone apps [ 36 - 44 ], and telephone counseling or video-based telehealth [ 45 - 51 ].
Yet these technology-based interventions suggest that it may be highly feasible and efficacious to use technology to intervene in families of youth with T1D. Moreover, using technology to intervene may be more scalable than in-person clinic delivery and enable behavioral interventions to reach a broader patient population, including families living in rural and underserved locations. This study will fill an existing gap in the current T1D literature by developing and testing a video-based telehealth intervention to reduce caregiver fear of hypoglycemia in families of young children.
Based on preliminary data, our primary hypotheses are 1 caregivers who receive REDCHiP will report reductions in parenting stress and fear of hypoglycemia compared with caregivers who receive the attention control intervention and 2 children of caregivers who receive REDCHiP will achieve more optimal glycemic control than children of caregivers who receive the attention control intervention.
REDCHiP includes a cognitive behavioral framework based on the conceptualization that caregiver fear of hypoglycemia is a type of specific phobia. In REDCHiP, caregivers learn to recognize and alter thoughts and behaviors driven by fear of hypoglycemia and gain new behavioral parenting strategies and coping strategies to help them manage their fear. Qualitatively, caregivers reported positive increases in knowledge, fear awareness, coping, and confidence and satisfaction with the support they received and the new behavioral parenting skills they learned from the REDCHiP intervention [ 54 ].
Quantitatively, caregivers experienced ificant reductions in fear of hypoglycemia, parenting stress, and T1D-related distress [ 55 ]. We used two approaches to determine the content of our attention control intervention. First, parents of young children ages 1 to 6 years provided input by reviewing a list of potential topics and rating each topic on a 3-point scale according to its degree of relevance to them not relevant, somewhat relevant, or very relevant. We then selected the topics identified as very relevant by the majority of caregivers.
Second, we asked 5 experts in Looking for cam sex of Harrington and hypoglycemic child development and clinical psychology to review our initial list of topics and the list of topics caregivers provided and provide recommendations for additional developmentally and age-appropriate topics.
The final list of sessions includes topics relevant to young children eg, developmental milestones, child health and safety, starting schoolpositive parenting strategies, and early literacy; caregivers do not learn about T1D-related topics.
To complement the REDCHiP format, the attention control intervention consists of 7 group and 3 individual sessions that are each 30 to 60 minutes in duration Table 2. We carefully deed the trial to reduce the impact of several potential challenges. First, we anticipated a challenge in recruiting an adequate sample because in very young children, T1D occurs at a prevalence of 0.
Therefore, we deed a multisite trial, which should enable us to adequately recruit our anticipated sample. Second, we anticipated barriers related to family availability and scheduling. To minimize this barrier, we deed the trial to deliver treatments via telehealth and include an option for families to complete study visits from home. Therefore, we have the flexibility in our trial de to loan web-enabled tablets to families.
Fourth, we considered the possibility that some families might not find the intervention content or telehealth delivery favorable and will withdraw.
This is a multisite trial and follows National Institutes of Health guidelines to establish and operate within a single institutional review board IRB for final study monitoring. All research personnel will complete certification in responsible conduct of research, good clinical practice, and safe handling of biological samples. To minimize risk for participating families, we will inform all potential families of the purpose, procedures, and amount of time required to participate in the trial.
We will minimize risk of breach of confidentiality by using a Health Insurance Portability and ability Act HIPAA -compliant telehealth platform and reviewing a group confidentiality agreement at the first session. Finally, we will protect caregivers by reviewing their responses on the study surveys within 24 hours of completion and contacting those who report concerning levels of depressive or anxiety symptoms to provide information on treatment resources. The trial was registered at ClinicalTrials. The REDCHiP intervention builds on our research examining fear of hypoglycemia in caregivers of young children with T1D and fills a critical gap in behavioral intervention research in these understudied families.
Moreover, the group-based telehealth approach is relatively novel for pediatric T1D interventions and may be easily scalable if the trial confirm efficacy. We plan to disseminate the of this trial to the pediatric diabetes community and broader medical community through national and international presentations at relevant scientific meetings and peer-reviewed manuscripts. We believe that there will be greater use of telehealth to deliver behavioral treatments for families of youth with T1D in the future because of the increasing adoption of telemedicine parity laws across the United States [ 57 ] and increased affinity for technology-enabled solutions to common needs in younger generations [ 58 ], including the need for convenient health care access [ 59 ].
We believe the format and general content of REDCHiP may be amenable to caregivers of older youth with T1D who also struggle with fear of hypoglycemia. Last, we expect that REDCHiP is in line with initiatives from the National Institute of Diabetes and Digestive and Kidney Diseases, which call for the development of more family-centered, efficacious, cost-effective, and easily scalable behavioral health interventions [ 60 ].
For this randomized clinical trial, we will recruit families of young children with T1D. Inclusion criteria are child aged from 2 to 5.
Each site will apply standardized recruitment procedures approved by a single IRB to achieve the target sample. We will use a combination of in-clinic and telephone recruitment. Families who express interest in participating via telephone will complete IRB-approved telephone informed consent procedures including an approved eConsent developed in the Research Electronic Data Capture REDCap system [ 6162 ].
Families recruited in person may complete an eConsent or standard paper consent. This study will use a 2-arm randomized attention control de with 90 families recruited to each of the REDCHiP and attention control intervention conditions. Recruitment and randomization will occur simultaneously across all participating sites using site-specific randomization envelopes prepared by the study biostatistician. This strategy will allow us to populate groups using caregivers from any site, thereby improving our recruitment efficiency and minimizing possible clinic effects.
We will also teach caregivers how to glucometer and insulin pump data from home to a central study database using a commercially available data aggregating system Glooko. In cases where caregivers cannot use the data aggregating system because of problems with device compatibility, we will collect. We will collect a finger stick blood sample from children using a reliable mail-in kit to measure a baseline HbA 1c level. Finally, we will determine if caregivers need to borrow any equipment to participate in the intervention eg, web camera, microphone, or tablet.
After study visit 1, caregivers will begin participating in video-based telehealth sessions according to their group asment eg, REDCHiP or attention control intervention. Caregivers will participate in 10 video-based telehealth sessions administered during 13 weeks via a HIPAA-compliant telehealth platform that permits multiparticipant video teleconferencing so that each caregiver can both see and hear other caregivers.
During weeks 14 to 15 of the trial, all families will engage in study visit 2 to complete posttreatment surveys online, collect accelerometry data from children and caregivers, collect child CGM data and finger stick blood sample to measure child HbA 1cand recover any loaned study-related devices.
Approximately 12 weeks after study visit 2, all families will complete study visit 3, which will involve final data collection: online surveys, child CGM data, and a finger stick blood sample to measure child HbA 1c Figure 2 and Table 3. Of note, the study protocol will enable families to complete study visits either in their home, at the diabetes clinic, or Looking for cam sex of Harrington and hypoglycemic another location eg, library. Additionally, our protocol includes strategies to retain families in the study in the rare event that they move away eg, telehealth, online surveys, mail-in HbA 1c kits or recruit families who self-refer based on word of mouth or ClinicalTrials.
All participating caregivers and children will receive compensation for study visits 1 through 3. As needed, the study will use prepaid postage boxes for families to return study-related devices eg, accelerometers and CGM sensors to further reduce the burden on participating families.
We will measure parenting stress and caregiver fear of hypoglycemia using the Pediatric Inventory for Parents [ 64 ] and the Hypoglycemia Fear Survey—Parents of Young Children [ 1526 ], respectively. We will accommodate nonnormal outcome variables with log transformation, modeling with an appropriate generalized mixed model or nonparametric test. To determine long-term treatment effects, we will test for sustained improvement on outcome variables by modeling scores at study visit 3 as a function of visit 1 scores and condition REDCHiP versus attention control intervention.
To control the overall rate of type I errors, we will conduct these analyses only for variables with a statistically ificant condition effect in our primary analysis of treatment outcomes. We assessed power using a simulation study; each simulated dataset contained 40 clusters 20 REDCHiP, 20 attention control intervention of 4 to 5 participants each.
We fit a mixed model with a random cluster intercept and baseline score and condition as predictors to each of simulated data sets. For 40 groups averaging 3. Recognizing this trial will include a control group, which could attenuate our REDCHiP effect, if we conservatively reduce the standardized effect size to 0.
The first wave of the intervention began in December This trial will focus on families of young children with T1D and exclude children who are on conventional insulin therapy, which could limit some of its generalizability. However, we anticipate little negative impact from this decision because intensive insulin therapy is now the gold standard regimen for individuals with T1D.
Our trial includes numerous outcome measures, which increases the risk of missing data.
We have attempted to reduce the risk of missing data through device use eg, accelerometry to measure physical activity and sleep and online questionnaire access and data sharing. We intend to give caregivers free and accessible technology support before and during telehealth visits in order to reduce any disruptions due to difficulties with the telehealth platform.Looking for cam sex of Harrington and hypoglycemic
email: [email protected] - phone:(310) 614-2478 x 1244
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