Advancing Diabetes Management in Adolescents Using Health Information Technology
The study will compare three treatment strategies to look at the best clinical outcomes.
The investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes.
研究概览
地位
条件
详细说明
This study will compare three strategies for enhancing adherence to diabetes care in our population. The study will look at which strategy results in the best short-term clinical outcomes for the population. Also, the study will look at patient satisfaction of contact with his/her health care team, quality of life, and family dynamics.
The three arms are:
- HIT (health information technology) aided approach
- Contracted conflict-management strategy
- Combination of the HIT-aided approach and the contracted conflict management strategy
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Indiana
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Carmel、Indiana、美国、46032
- Riley Children's Specialties
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Indianapolis、Indiana、美国、46202
- Riley Children's Hospital
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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:
- Type 1 diabetes diagnosed for at least 6 months
- At least one or more parent/guardian who agrees to participate
Exclusion Criteria:
- Other chronic diseases with the exception of well-controlled asthma or treated thyroid disease
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:HIT-aided approach
Adolescents and their parents randomized to this arm will be oriented on a HIT system.
The system transmits self monitoring blood glucose self monitoring blood glucose data to a secure web portal.
The subject will receive messages from the HIT system on the meter based upon the Self Monitored Blood glucose tests.
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Subjects randomized to this approach will be using the HIT-aided monitor.
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实验性的:Contracted conflict management system
Adolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent.
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Subjects randomized to this arm will be using the behavioral contracted conflict management system.
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实验性的:HIT plus contracted conflict management
Adolescents and their parents randomized to this arm will be oriented on a HIT system.
The system transmits self monitoring blood glucose data to a secure web portal.
The subject will receive messages from the HIT system on the meter based upon the tests.
In addition, adolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent.
This arm combines arms 1 and 2.
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Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.
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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 using HBA1C
大体时间:Baseline, 3 months, and 6 months
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Change in Glycemic Control
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Baseline, 3 months, and 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Frequency of self monitoring blood glucose measurement
大体时间:Baseline, 3 months, 6 months
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change in Self-monitoring blood glucose measurement
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Baseline, 3 months, 6 months
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Quality of Life
大体时间:Baseline and 6 months
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Change in Diabetes-specific quality of life measures will be measured by the Varney's Pediatric Quality of Life 3.0 Diabetes Module.
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Baseline and 6 months
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Family dynamics
大体时间:Baseline and 6 months
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Change in family dynamics measured by the Cornell Parent Behavior Description Scale and the Helping for Health Inventory.
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Baseline and 6 months
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Treatment Adherence Behaviors
大体时间:Once per month for 6 months
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Change in treatment adherence behaviors measured by the Self-Care Inventory with supplemental questions determined by the investigator.
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Once per month for 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Satisfaction
大体时间:3 month and 6 month
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Patient and parent satisfaction with the intervention with questions determined by the investigator.
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3 month and 6 month
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合作者和调查者
调查人员
- 首席研究员:Tamara Hannon, MD、Indiana University School of Medicine
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 (估计)
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.
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