An Intervention to Improve Adolescent Headache Self-management

Pain Clinical Trial

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Official title:

An Intervention to Improve Adolescent Headache Self-management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475005
• Other study ID #: 2R44HD066920-03A1
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: February 27, 2018
• Start date: September 20, 2014
• Est. completion date: November 28, 2017

Study information

• Verified date: February 2018
• Source: Inflexxion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

[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

Related Conditions & MeSH terms

• Headache
• Pain

Intervention

Behavioral:
• pain self management app on smartphone

Locations

Country	Name	City	State
United States	Inflexxion	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stephen F Butler, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline	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
Secondary	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
Secondary	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: How many days in the past 30 days did his/her child see a healthcare provider for his/her headaches?; What types of treatment (including medications) has his/her child received for headaches in the past 30 days?	2 months, 3 months, 6 months