An Intervention to Improve Adolescent Headache Self-management (TH)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Newton, Massachusetts, Estados Unidos, 02464
- Inflexxion
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
[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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mobile self management app on smartphone
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|
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Sin intervención: Treatment as usual
Treatment as usual (control group)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in pain coping at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 2 months, 3 months, 6 months
|
Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
|
2 months, 3 months, 6 months
|
|
Change in headache intensity at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 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
|
2 months, 3 months, 6 months
|
|
Change in headache frequency at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 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?"
|
2 months, 3 months, 6 months
|
|
Change in quality of life at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 2 months, 3 months, 6 months
|
Measured by PedMIDAS - Hershey et al., 2001
|
2 months, 3 months, 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 2 months, 3 months, 6 months
|
Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006
|
2 months, 3 months, 6 months
|
|
Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 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
|
|
Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 2 months, 3 months, 6 months
|
Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)
|
2 months, 3 months, 6 months
|
|
Change in health care utilization at 2 months, 3 months, and 6 months post-baseline
Periodo de tiempo: 2 months, 3 months, 6 months
|
Measured by asking caregiver to report information such as the following:
|
2 months, 3 months, 6 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2R44HD066920-03A1 (Subvención/contrato del NIH de EE. UU.)
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