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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile self management app on smartphone | Experimental | Mobile self management app on smartphone |
|
| Treatment as usual | No Intervention | Treatment as usual (control group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pain self management app on smartphone | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain coping at 2 months, 3 months, and 6 months post-baseline | Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998 | 2 months, 3 months, 6 months |
| Change in headache intensity at 2 months, 3 months, and 6 months post-baseline | "In the past 7 days, how would you rate your headache pain on average..." from 0-no pain to 10-worst possible pain | 2 months, 3 months, 6 months |
| Change in headache frequency at 2 months, 3 months, and 6 months post-baseline | 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?" | 2 months, 3 months, 6 months |
| Change in quality of life at 2 months, 3 months, and 6 months post-baseline | Measured by PedMIDAS - Hershey et al., 2001 | 2 months, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline | Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006 | 2 months, 3 months, 6 months |
| Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline |
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[The above age limits are specific to adolescent participants.]
Inclusion Criteria - Adolescents
Exclusion Criteria - Adolescents
Inclusion Criteria - Caregivers
Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflexxion | Newton | Massachusetts | 02464 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006261 | Headache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Ask caregivers: "How many full school days did your child miss in the past 30 days due to headaches?" |
| 2 months, 3 months, 6 months |
| Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline | Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999) | 2 months, 3 months, 6 months |
| Change in health care utilization at 2 months, 3 months, and 6 months post-baseline | Measured by asking caregiver to report information such as the following:
| 2 months, 3 months, 6 months |