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An Intervention to Improve Adolescent Headache Self-management (TH)

This study is not yet open for participant recruitment.
Verified March 2016 by Kimberlee Trudeau, Inflexxion, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02475005
First Posted: June 18, 2015
Last Update Posted: March 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Kimberlee Trudeau, Inflexxion, Inc.
  Purpose
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.

Condition Intervention
Pain Headache Behavioral: pain self management app on smartphone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Intervention to Improve Adolescent Headache Self-management

Resource links provided by NLM:


Further study details as provided by Kimberlee Trudeau, Inflexxion, Inc.:

Primary Outcome Measures:
  • Change in pain coping at 2 months, 3 months, and 6 months post-baseline [ Time Frame: 2 months, 3 months, 6 months ]
    Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998

  • Change in headache intensity at 2 months, 3 months, and 6 months post-baseline [ Time Frame: 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 [ Time Frame: 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?"

  • Change in quality of life at 2 months, 3 months, and 6 months post-baseline [ Time Frame: 2 months, 3 months, 6 months ]
    Measured by PedMIDAS - Hershey et al., 2001


Secondary Outcome Measures:
  • Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline [ Time Frame: 2 months, 3 months, 6 months ]
    Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006

  • Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline [ Time Frame: 2 months, 3 months, 6 months ]
    Ask caregivers: "How many full school days did your child miss in the past 30 days due to headaches?"

  • Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline [ Time Frame: 2 months, 3 months, 6 months ]
    Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)

  • Change in health care utilization at 2 months, 3 months, and 6 months post-baseline [ Time Frame: 2 months, 3 months, 6 months ]

    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?


Estimated Enrollment: 144
Study Start Date: May 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mobile self management app on smartphone
Mobile self management app on smartphone
Behavioral: pain self management app on smartphone
No Intervention: Treatment as usual
Treatment as usual (control group)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475005


Contacts
Contact: Kelly Manser teenheadachestudy@inflexxion.com

Sponsors and Collaborators
Inflexxion, Inc.
University of California, Los Angeles
  More Information

Responsible Party: Kimberlee Trudeau, Senior Research Scientist, Inflexxion, Inc.
ClinicalTrials.gov Identifier: NCT02475005     History of Changes
Other Study ID Numbers: 2R44HD066920-03A1 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2015
First Posted: June 18, 2015
Last Update Posted: March 10, 2016
Last Verified: March 2016

Keywords provided by Kimberlee Trudeau, Inflexxion, Inc.:
self management app
headache
adolescent

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms