Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Colorado
-
Aurora、Colorado、美国、80045
- Barbara Davis Center for Childhood Diabetes
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Home Telehealth T1D (CoYoT1-HR)
Home Telehealth T1D (C2oYoT1-HR), standard of care delivered via Telehealth for high-risk youth
|
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.
其他名称:
|
实验性的:Personalized Adherence Feedback
C2oYoT1-HR+Personalized Adherence Intervention
|
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.
其他名称:
|
实验性的:Personalized Behavioral Health
C2oYoT1-HR+Personalized Behavioral Health
|
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.
其他名称:
|
实验性的:C2oYoT1-HR + Adherence + Behavioral
C2oYoT1-HR + both Personalized Adherence Feedback + Personalized Behavioral Health (C2oYoT1-HR + Adherence + Behavioral)
|
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.
其他名称:
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.
其他名称:
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.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Glycemic control (A1C): Change from baseline and every 12 weeks up to 72 weeks (18 mo)
大体时间:weeks 1, 12, 24, 36, 48, 72
|
A1C will be measured in the central lab located within the Barbara Davis Center at Study Visits 1 (week 1), 5 (week 24) and 9 (week 48), and Follow-Up Visit 2 (week 72) or 4 (week 72) which correspond to in-person T1D visits.
In addition, participants will be asked to complete A1C measurements at an outside, independent Certified Laboratory Improvement Amendments (CLIA) lab prior to home telehealth T1D Study Visits 3 (week 12) and 7 (week 36).
The rationale for measurement at these study visits is that they occur every 3 months, which is the interval in which A1C is measured as standard of care.
Change in A1c will be looked at from baseline every 3 months throughout the study.
|
weeks 1, 12, 24, 36, 48, 72
|
Hyperglycemia - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
大体时间:weeks 1, 12, 24, 36, 48, 72
|
Time spent in hyperglycemia - change will be looked at from baseline every 12 weeks throughout the study.
|
weeks 1, 12, 24, 36, 48, 72
|
Pediatric Diabetes Quality of Life Scale - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
大体时间:weeks 1, 12, 24, 36, 48, 72
|
The PDQ is a 20-question self-administered scale that evaluates and quantifies the quality of life as related to diabetes - change will be looked at from baseline every 3 months throughout the study.
|
weeks 1, 12, 24, 36, 48, 72
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Adherence - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
大体时间:weeks 1, 12, 24, 36, 48, 72
|
Objectively Measured Adherence, Self-Reported Adherence, Number of T1D Appointments Attended.
- change will be looked at from baseline every 3 months throughout the study.
|
weeks 1, 12, 24, 36, 48, 72
|
Psychosocial Measures - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
大体时间:weeks 1, 24, 48, 72
|
Diabetes Family Conflict Scale (DFCS), Diabetes Family Responsibility Questionnaire (DFRQ), Hypoglycemia Fear Scale (HFS), Patient Health Questionnaire - 9 (PHQ-9), Problem Area in Diabetes Version (PAID), Puberty - change will be looked at from baseline every 3 months throughout the study.
|
weeks 1, 24, 48, 72
|
Biological Markers of T1D Complications - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
大体时间:weeks 1, 24, 48, 72
|
Urinary microalbumin, endothelial function - change will be looked at from baseline every 3 months throughout the study.
|
weeks 1, 24, 48, 72
|
合作者和调查者
调查人员
- 首席研究员:Kimberly A Driscoll, PhD、University of Colorado, Denver
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.