An Intervention to Improve Adolescent Headache Self-management (TH)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Newton, Massachusetts, Stati Uniti, 02464
- Inflexxion
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
[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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Mobile self management app on smartphone
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Nessun intervento: Treatment as usual
Treatment as usual (control group)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in pain coping at 2 months, 3 months, and 6 months post-baseline
Lasso di tempo: 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
Lasso di tempo: 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
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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
Lasso di tempo: 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?"
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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
Lasso di tempo: 2 months, 3 months, 6 months
|
Measured by PedMIDAS - Hershey et al., 2001
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2 months, 3 months, 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
Lasso di tempo: 2 months, 3 months, 6 months
|
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
Lasso di tempo: 2 months, 3 months, 6 months
|
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
Lasso di tempo: 2 months, 3 months, 6 months
|
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
Lasso di tempo: 2 months, 3 months, 6 months
|
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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2R44HD066920-03A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dolore
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University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team