PainTHNCT02475005
An Intervention to Improve Adolescent Headache Self-management
A study testing pain self management app on smartphone in people with Pain and Headache, run by Stephen F Butler, PhD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- What is being tested?
- pain self management app on smartphone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2014to 28 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- pain self management app on smartphone
- Keywords
- self management app, headache, adolescent
- Medical subject headings
- Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain self management app on smartphoneBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mobile self management app on smartphone | Experimental | Mobile self management app on smartphone Receives: Behavioral: pain self management app on smartphone |
| Treatment as usual | No intervention | Treatment as usual (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain coping at 2 months, 3 months, and 6 months post-baseline
Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
Measured: 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
Measured: 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?"
Measured: 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
Measured: 2 months, 3 months, 6 months
Secondary outcomes (4)
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
Measured: 2 months, 3 months, 6 months
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?"
Measured: 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)
Measured: 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:
- 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?
Measured: 2 months, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start20 Sep 2014
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen F Butler, PhD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Stephen F Butler, PhD, Inflexxion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475005
- Sponsor's protocol ID
- 2R44HD066920-03A1
- Acronym
- TH
- Status last verified
- Feb 2018
- First submitted
- 12 Jun 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Improve Adolescent Headache Self-management
- ClinicalTrials.gov ID
- NCT02475005
- Acronym / sponsor ID
- TH / 2R44HD066920-03A1
- Keywords
- self management app, headache, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Stephen F Butler, PhDIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2014 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile self management app on smartphone | Experimental | Behavioral: pain self management app on smartphoneMobile self management app on smartphone |
| Treatment as usual | No intervention | –Treatment as usual (control group) |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
- Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain self management app on smartphone | Behavioural | Mobile self management app on smartphone |
Primary outcome
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
4 secondary outcomes
Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
Time frame: 2 months, 3 months, 6 months
Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline
Time frame: 2 months, 3 months, 6 months
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
Change in health care utilization at 2 months, 3 months, and 6 months post-baseline
Time frame: 2 months, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain self management app on smartphone in people with Pain and Headache, run by Stephen F Butler, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain coping at 2 months, 3 months, and 6 months post-baseline (time frame: 2 months, 3 months, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.