- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00860834
Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study) (PARTNER)
Parents, Pediatricians, and Telephone Coaches Partner to Improve Control of Asthma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Asthma is the most common long-term disease among children. Each year, most children with asthma will have at least one asthma exacerbation, experience asthma symptoms on approximately 100 days, and miss 4 days of school because of asthma. Surveys of primary care physicians (PCPs) and asthma patients have indicated that asthma care is episodic, effective asthma controller medications are underused, and few PCPs provide self-management education or support for parents of children with asthma. Previous research showed that when an asthma coach worked with parents of children from low-income, urban neighborhoods, there were multiple benefits: improved self-management behaviors, reduced asthma hospitalizations, and improved rates of follow-up with a PCP after an emergency department visit for asthma symptoms. In this study, researchers will evaluate the effectiveness of an asthma coach program in a larger, general asthma population. Trained asthma coaches will work with parents of children with asthma to provide education about the goals of asthma care, and they will encourage and facilitate an active partnership between the family and PCP to enhance asthma care and improve self-management behaviors. Study researchers will then evaluate the effectiveness of this program at improving asthma control and quality of life among children with asthma. The cost effectiveness of the program will also be analyzed.
This study will enroll pediatricians and parents of children between 5 and 12 years old who have persistent asthma. Pediatricians will be randomly assigned to either the asthma coach program or usual care. All pediatricians will receive access to the Education in Quality Improvement for Pediatric Practice (eQIPP) module for asthma care provided by the American Academy of Pediatrics. They will also receive articles about effective doctor-parent communication on asthma and asthma billing practices. In addition, pediatricians taking part in the asthma coach program will attend two meetings to learn about asthma coaching and how the program can be implemented into their practice. For 12 months, an asthma coach will work directly with the parents of children who see doctors participating in the asthma coaching group. Telephone calls with the asthma coach will be arranged at times convenient for the parent and will occur anywhere between once a week to once a month. At Months 12 and 24, about 40 parents of children in each pediatrician's practice will participate in telephone interviews and their children's medical charts will be reviewed to assess asthma control, asthma-related quality of life factors, and urgent care events.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria for Pediatricians:
- Affiliated with St. Louis Children's Hospital and/or Washington University in St. Louis
- Provides asthma care for at least 40 asthmatic children from the target population
Inclusion Criteria for Parents:
- Has a child who is between 3 and 12 years old with persistent asthma and who is cared for by a study pediatrician
Exclusion Criteria for Pediatricians:
- Spends less than 50% of their time in general pediatrics
- Is an asthma specialist (allergist or pulmonary specialist)
- Another physician in their practice is participating in the study
Exclusion Criteria for Parents:
- Their asthmatic child is less than 3 years old or is 13 years or older at the time of study entry
- Their child has not had a physician diagnosis of asthma before study entry
- Their child has a significant comorbid condition
- Cannot speak English
- Does not have a phone
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 1
Pediatricians and parents of children with asthma will participate in the asthma coaching program.
|
Parents will have access to an asthma coach for 12 months.
Telephone calls between parents and coaches will occur anywhere from once a week to once a month.
|
Comparador Ativo: 2
Children of parents enrolled in the study will receive usual asthma care from their pediatrician.
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Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Asthma control
Prazo: Measured at Months 12 and 24
|
Measured at Months 12 and 24
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Asthma-related quality of life
Prazo: Measured at Months 12 and 24
|
Measured at Months 12 and 24
|
Urgent care events
Prazo: Measured at Months 12 and 24
|
Measured at Months 12 and 24
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Adherence to guideline-recommended asthma maintenance care behaviors
Prazo: Measured at Months 12 and 24
|
Measured at Months 12 and 24
|
Cost effectiveness
Prazo: Measured at Months 12 and 24
|
Measured at Months 12 and 24
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Strunk, MD, Washington University School of Medicine
- Investigador principal: Jane M. Garbutt, MB, ChB, Washington University School of Medicine
Publicações e links úteis
Publicações Gerais
- Garbutt JM, Highstein G, Yan Y, Strunk RC. Partner randomized controlled trial: study protocol and coaching intervention. BMC Pediatr. 2012 Apr 2;12:42. doi: 10.1186/1471-2431-12-42.
- Garbutt JM, Yan Y, Highstein G, Strunk RC. A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity. J Allergy Clin Immunol. 2015 May;135(5):1163-70.e1-2. doi: 10.1016/j.jaci.2014.09.033. Epub 2014 Oct 30.
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
- 634
- R01HL072919 (Concessão/Contrato do NIH dos EUA)
- R01HL072919-06 (Concessão/Contrato do NIH dos EUA)
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