An Intervention to Improve Adolescent Headache Self-management (TH)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Newton, Massachusetts, 미국, 02464
- Inflexxion
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
[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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Mobile self management app on smartphone
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간섭 없음: Treatment as usual
Treatment as usual (control group)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in pain coping at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
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2 months, 3 months, 6 months
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Change in headache intensity at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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"In the past 7 days, how would you rate your headache pain on average..." from 0-no pain to 10-worst possible pain
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2 months, 3 months, 6 months
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Change in headache frequency at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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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?"
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2 months, 3 months, 6 months
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Change in quality of life at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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Measured by PedMIDAS - Hershey et al., 2001
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2 months, 3 months, 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006
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2 months, 3 months, 6 months
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Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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Ask caregivers: "How many full school days did your child miss in the past 30 days due to headaches?"
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2 months, 3 months, 6 months
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Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)
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2 months, 3 months, 6 months
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Change in health care utilization at 2 months, 3 months, and 6 months post-baseline
기간: 2 months, 3 months, 6 months
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Measured by asking caregiver to report information such as the following:
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2 months, 3 months, 6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
통증에 대한 임상 시험
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Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
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Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
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Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
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Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)