An Intervention to Improve Adolescent Headache Self-management (TH)
研究概览
详细说明
Headaches dramatically affect adolescents' overall functioning and quality of life. We have developed a highly engaging mobile-based program that will help adolescents to make connections between behaviors and symptoms, and to ultimately improve functioning and quality of life. The mobile-based program will provide a state of the art pain tracker, a variety of coping strategies, and information about self-management of symptoms. This app will offer a maximally engaging way to help adolescents track their pain, make connections between lifestyle and pain, and learn key self-management skills.
The study involves the participant being randomized into either the experimental group, where he/she will be using this mobile application to track their headache symptoms, or the control group, where he/she will receive headache treatment as usual; the control group will not be using an app for this study. The intervention will last for two months.
Participants will be assessed at baseline, at 2-months post baseline, at 3-months post baseline, and at 6-months post baseline. All participants will be asked to complete online questionnaires about their headaches. We plan to enroll 144 adolescent participants with headaches, as well as one caregiver (meaning a parent/guardian) for each adolescent.
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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Massachusetts
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Newton、Massachusetts、美国、02464
- Inflexxion
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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
[The above age limits are specific to adolescent participants.]
Inclusion Criteria - Adolescents
- Between ages 13 and 17 (inclusive)
- Able to read and speak English
- Has recurring headaches that are not related to another medical condition
- iPhone user with access to an iPhone [4/4S or later] for use during the intervention period
Exclusion Criteria - Adolescents
- Secondary headache or seizure disorder. Examples include: increased intracranial pressure, hydrocephalus, traumatic brain injury, benign or cancerous brain
- Cognitive impairment or psychiatric condition that would interfere with ability to use the mobile application or complete the assessments
Inclusion Criteria - Caregivers
Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants
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：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 |
|---|---|
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实验性的：Mobile self management app on smartphone
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无干预：Treatment as usual
Treatment as usual (control group)
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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 |
|---|---|---|
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Change in pain coping at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
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2 months, 3 months, 6 months
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Change in headache intensity at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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"In the past 7 days, how would you rate your headache pain on average..." from 0-no pain to 10-worst possible pain
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2 months, 3 months, 6 months
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Change in headache frequency at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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On how many days during the past 30 days have you had a headache?
How many days in the past 30 were you completely headache free?"
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2 months, 3 months, 6 months
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Change in quality of life at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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Measured by PedMIDAS - Hershey et al., 2001
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2 months, 3 months, 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006
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2 months, 3 months, 6 months
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Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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Ask caregivers: "How many full school days did your child miss in the past 30 days due to headaches?"
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2 months, 3 months, 6 months
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Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)
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2 months, 3 months, 6 months
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Change in health care utilization at 2 months, 3 months, and 6 months post-baseline
大体时间：2 months, 3 months, 6 months
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Measured by asking caregiver to report information such as the following:
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2 months, 3 months, 6 months
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合作者和调查者
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
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