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

Primary Purpose

Pain, Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pain self management app on smartphone
Sponsored by
Stephen F Butler, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring self management app, headache, adolescent

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

[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

Sites / Locations

  • Inflexxion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile self management app on smartphone

Treatment as usual

Arm Description

Mobile self management app on smartphone

Treatment as usual (control group)

Outcomes

Primary Outcome Measures

Change in pain coping at 2 months, 3 months, and 6 months post-baseline
Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
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
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?"
Change in quality of life at 2 months, 3 months, and 6 months post-baseline
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
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
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
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
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?

Full Information

First Posted
June 12, 2015
Last Updated
February 27, 2018
Sponsor
Stephen F Butler, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT02475005
Brief Title
An Intervention to Improve Adolescent Headache Self-management
Acronym
TH
Official Title
An Intervention to Improve Adolescent Headache Self-management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 20, 2014 (Actual)
Primary Completion Date
November 28, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen F Butler, PhD

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Headache
Keywords
self management app, headache, adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile self management app on smartphone
Arm Type
Experimental
Arm Description
Mobile self management app on smartphone
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual (control group)
Intervention Type
Behavioral
Intervention Name(s)
pain self management app on smartphone
Primary Outcome Measure Information:
Title
Change in pain coping at 2 months, 3 months, and 6 months post-baseline
Description
Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
Time Frame
2 months, 3 months, 6 months
Title
Change in headache intensity at 2 months, 3 months, and 6 months post-baseline
Description
"In the past 7 days, how would you rate your headache pain on average..." from 0-no pain to 10-worst possible pain
Time Frame
2 months, 3 months, 6 months
Title
Change in headache frequency at 2 months, 3 months, and 6 months post-baseline
Description
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?"
Time Frame
2 months, 3 months, 6 months
Title
Change in quality of life at 2 months, 3 months, and 6 months post-baseline
Description
Measured by PedMIDAS - Hershey et al., 2001
Time Frame
2 months, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
Description
Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006
Time Frame
2 months, 3 months, 6 months
Title
Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline
Description
Ask caregivers: "How many full school days did your child miss in the past 30 days due to headaches?"
Time Frame
2 months, 3 months, 6 months
Title
Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline
Description
Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)
Time Frame
2 months, 3 months, 6 months
Title
Change in health care utilization at 2 months, 3 months, and 6 months post-baseline
Description
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?
Time Frame
2 months, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Inflexxion
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02464
Country
United States

12. IPD Sharing Statement

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An Intervention to Improve Adolescent Headache Self-management

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