An Intervention to Improve Adolescent Headache Self-management (TH)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Newton、Massachusetts、アメリカ、02464
- Inflexxion
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
[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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Mobile self management app on smartphone
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介入なし：Treatment as usual
Treatment as usual (control group)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pain coping at 2 months, 3 months, and 6 months post-baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
痛みの臨床試験
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Dexa Medica Group完了