Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02475005
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention to Improve Adolescent Headache Self-management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-17', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain coping at 2 months, 3 months, and 6 months post-baseline', 'timeFrame': '2 months, 3 months, 6 months', 'description': 'Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998'}, {'measure': 'Change in headache intensity at 2 months, 3 months, and 6 months post-baseline', 'timeFrame': '2 months, 3 months, 6 months', 'description': '"In the past 7 days, how would you rate your headache pain on average..." from 0-no pain to 10-worst possible pain'}, {'measure': 'Change in headache frequency at 2 months, 3 months, and 6 months post-baseline', 'timeFrame': '2 months, 3 months, 6 months', '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?"'}, {'measure': 'Change in quality of life at 2 months, 3 months, and 6 months post-baseline', 'timeFrame': '2 months, 3 months, 6 months', 'description': 'Measured by PedMIDAS - Hershey et al., 2001'}], 'secondaryOutcomes': [{'measure': 'Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline', 'timeFrame': '2 months, 3 months, 6 months', 'description': 'Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006'}, {'measure': 'Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline', 'timeFrame': '2 months, 3 months, 6 months', 'description': 'Ask caregivers: "How many full school days did your child miss in the past 30 days due to headaches?"'}, {'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', 'description': 'Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)'}, {'measure': 'Change in health care utilization at 2 months, 3 months, and 6 months post-baseline', 'timeFrame': '2 months, 3 months, 6 months', 'description': 'Measured by asking caregiver to report information such as the following:\n\n* How many days in the past 30 days did his/her child see a healthcare provider for his/her headaches?\n* What types of treatment (including medications) has his/her child received for headaches in the past 30 days?'}]}, 'conditionsModule': {'keywords': ['self management app', 'headache', 'adolescent'], 'conditions': ['Pain', 'Headache']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '\\[The above age limits are specific to adolescent participants.\\]\n\nInclusion Criteria - Adolescents\n\n* Between ages 13 and 17 (inclusive)\n* Able to read and speak English\n* Has recurring headaches that are not related to another medical condition\n* iPhone user with access to an iPhone \\[4/4S or later\\] for use during the intervention period\n\nExclusion Criteria - Adolescents\n\n* Secondary headache or seizure disorder. Examples include: increased intracranial pressure, hydrocephalus, traumatic brain injury, benign or cancerous brain\n* Cognitive impairment or psychiatric condition that would interfere with ability to use the mobile application or complete the assessments\n\nInclusion Criteria - Caregivers\n\nParent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants'}, 'identificationModule': {'nctId': 'NCT02475005', 'acronym': 'TH', 'briefTitle': 'An Intervention to Improve Adolescent Headache Self-management', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inflexxion, Inc.'}, 'officialTitle': 'An Intervention to Improve Adolescent Headache Self-management', 'orgStudyIdInfo': {'id': '2R44HD066920-03A1', 'link': 'https://reporter.nih.gov/quickSearch/2R44HD066920-03A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile self management app on smartphone', 'description': 'Mobile self management app on smartphone', 'interventionNames': ['Behavioral: pain self management app on smartphone']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Treatment as usual (control group)'}], 'interventions': [{'name': 'pain self management app on smartphone', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mobile self management app on smartphone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02464', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Inflexxion', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stephen F Butler, PhD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior VP/Chief Science Officer', 'investigatorFullName': 'Stephen F Butler, PhD', 'investigatorAffiliation': 'Inflexxion, Inc.'}}}}