Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 6/2/2018 |
| Start Date: | November 1, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Kimberly A Driscoll, PhD |
| Email: | kimberly.driscoll@ucdenver.edu |
| Phone: | 3037249910 |
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.
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.
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.
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.
Inclusion Criteria:
- youth age 10-17 years
- A1C=9-12%
- parent(s) of child with confirmed diagnosis of T1D
- T1D duration >1 year
- parent and child agree to participate in home telehealth sessions
- ability to use telehealth equipment (i.e., computer, tablet, smartphone with internet
connectivity)
Exclusion Criteria:
- developmental disability or reading disorder that prevents understanding of the
intervention materials
- non-English speaking adolescents
- those with severe psychological disorders
- prescribed and taking medications that increase blood glucoses
- not seen in T1D clinic within the past year; pregnant if female; situational concerns
(e.g., active custody battle)
- type 2 diabetes
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