An Intervention to Improve Adolescent Headache Self-management (TH)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Newton, Massachusetts, Estados Unidos, 02464
- Inflexxion
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
[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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Mobile self management app on smartphone
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Sem intervenção: Treatment as usual
Treatment as usual (control group)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in pain coping at 2 months, 3 months, and 6 months post-baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2R44HD066920-03A1 (Concessão/Contrato do NIH dos EUA)
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Ensaios clínicos em pain self management app on smartphone
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University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Concluído