Clinical trial NCT02475005: An Intervention to Improve Adolescent Headache Self-management
Official title: An Intervention to Improve Adolescent Headache Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Headache
Keywords: self management app
headache
adolescent
Lead sponsor: Inflexxion, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: \[The above age limits are specific to adolescent participants.\]

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

Primary outcomes:
measure: Change in pain coping at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
measure: Change in headache intensity at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
measure: Change in headache frequency at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
measure: Change in quality of life at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
Secondary outcomes:
measure: Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
measure: Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
measure: Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
measure: Change in health care utilization at 2 months, 3 months, and 6 months post-baseline
timeFrame: 2 months, 3 months, 6 months
Other outcomes:
Locations:
city: Newton
country: United States
facility: Inflexxion
state: Massachusetts
Study officials:
References: