An Intervention to Improve Adolescent Headache Self-management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Change in pain coping at 2 months, 3 months, and 6 months post-baseline
研究概览
简要总结
The purpose of this study is to test the efficacy of a new app to help adolescents with chronic or reoccurring headaches self manage pain.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[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
排除标准
- •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
研究组 & 干预措施
Mobile self management app on smartphone
Mobile self management app on smartphone
干预措施: pain self management app on smartphone (Behavioral)
Treatment as usual
Treatment as usual (control group)
结局指标
主要结局
Change in pain coping at 2 months, 3 months, and 6 months post-baseline
时间窗: 2 months, 3 months, 6 months
Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
Change in quality of life at 2 months, 3 months, and 6 months post-baseline
时间窗: 2 months, 3 months, 6 months
Measured by PedMIDAS - Hershey et al., 2001
Change in headache intensity at 2 months, 3 months, and 6 months post-baseline
时间窗: 2 months, 3 months, 6 months
"In the past 7 days, how would you rate your headache pain on average..." from 0-no pain to 10-worst possible pain
Change in headache frequency at 2 months, 3 months, and 6 months post-baseline
时间窗: 2 months, 3 months, 6 months
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?"
次要结局
- Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline(2 months, 3 months, 6 months)
- Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline(2 months, 3 months, 6 months)
- Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline(2 months, 3 months, 6 months)
- Change in health care utilization at 2 months, 3 months, and 6 months post-baseline(2 months, 3 months, 6 months)
研究者
Stephen F Butler, PhD
Senior VP/Chief Science Officer
Inflexxion, Inc.