Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in
      high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal
      glycemic control has severe acute and long-term complications with potentially life
      threatening consequences. Lack of regular contact with T1D care providers, continued T1D
      nonadherence, and suboptimal behavioral and mental health functioning compromises the
      physical health of youth with T1D and the ability of T1D teams to provide effective
      treatment. If the aims of this study are achieved, this study will change T1D care practices
      by providing high-risk youth with T1D, and their parents, medical and behavioral health
      support via home telehealth intervention. This has the potential to significantly change
      access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital
      admissions, and improve glycemic control. In addition, this study's use of Multiphase
      Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective
      intervention components, should be generalizable to all individuals with T1D, leading to
      cost-effective, home telehealth intervention programs. Innovative aspects include: 1)
      assessment of physical and behavioral health characteristics associated with high-risk
      status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health
      care delivered with the endocrinologist and behavioral health specialist working together
      with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical
      health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D
      clinical health outcomes; and 3) an underused methodological approach for optimizing
      intervention components to be delivered at point of care.
    

Detailed description: 
      AIM 1: PHASE 1: Use Multiphasic Optimization Strategy (i.e., MOST), a highly efficient
      experimental strategy, to determine specific components for inclusion in an intervention to
      1a) improve primary clinical outcomes of A1C and percentage of time spent in hyperglycemia
      and 1b) address secondary clinical outcomes by improving adherence and biological markers of
      complications in high-risk pediatric patients with T1D (A1C=9-12%) as part of 12-month
      personalized behavioral intervention delivered via in-person T1D clinic visits and home
      telemedicine.

      MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a
      2x2 factorial experiment, a highly efficient experimental design despite several common
      misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a
      4-arm trial in which each condition is compared in turn to a control condition. In fact,
      factorial designs do not require a larger number of participants than other designs (e.g.,
      Randomized Controlled Trials (RCT)) and when used to address suitable research questions,
      they require fewer participants than other designs. Adding factors does not require a
      dramatic increase in sample size to maintain power.

      H1: There will be a main effect of Personalized Adherence Intervention on percentage of A1C,
      time spent in hyperglycemia, adherence behaviors, and biological markers of complications.

      H2: There will be a main effect of Personalized Behavioral Health Intervention on percentage
      of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of
      complications.

      AIM 2: PHASE 2: Determine effectiveness of the intervention components on maintenance of A1C,
      percentage of time spent in hyperglycemia, adherence, and biological markers improvements
      throughout 6-month follow-up.

      H1: Participants who are randomized to T1D medical appointments every 6 weeks will show
      better improvements in gains in A1C, percentage of time spent in hyperglycemia, adherence,
      and biological markers compared to those participants who revert to medical appointments
      occurring every 3 months.
    

Intervention name(s): Home Telehealth T1D C2oYoT1-HR; Personalized Behavioral Health; Personalized Adherence Feedback
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.; 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.; 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Other intervention name(s): C2oYoT1-HR; C2oYoT1-HR + Behavioral Health; C2oYoT1-HR + Personalized Adherence Intervention
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., RCT) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power. The number of arms is listed below as 4 as # of arms is required by the clinicaltrails.gov site; please refer above for a more accurate description of the study design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics