- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02575326
Teen Asthma Control Encouraging a Healthier Lifestyle (TAC)
Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Asthma that has persisted in adolescents is likely to persist into adulthood. For 25-30% of Americans, adolescence is also the period at which they experience their greatest weight gain, particularly as they approach the final stages of puberty. Asthma management may be more of a challenge in the overweight adolescent compared to a normal weight youth. Asthma related morbidity is increased in overweight patients, reflected in higher health care utilization for this subgroup. Little guidance is given to physicians caring for obese adolescents with asthma, but findings suggest that interventions designated to achieve control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g. low self-esteem, depression and low quality of life) successful interventions should incorporate a patient-centered approach.
Patient-centered care (or patient focused care) involves a partnership between the patient and the physician, shared discussion making, as well as productive communication and health promotion. The objective of this project is to collect the information necessary to develop a tailored discussion guide for use by the physician caring for the obese teen with asthma. Project results will provide an evidence base for the development and evaluation of additional patient-centered health interventions for obese adolescents with asthma. The investigators will conduct this study among patients whom eligibility can be determined using the electronic medical record (EMR). The specific aims of this proposal are to:
Qualitatively collect information on outcomes important to obese adolescents with asthma:
Create a tailored discussion guide that incorporates patient preferences and treatment goals that can be used by providers caring for overweight adolescents with asthma:
Conduct a randomized trial to determine if patient-centered and clinical outcomes improve for patients whose physicians use the tailored discussion guide compared to those who do not.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48202
- Henry Ford System
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- BMI >85th Percentile & Diagnosed with asthma; using a modification of Healthcare Effectiveness Data and Information Set (HEDIS) criteria:
- At least one emergency department visit with a principal diagnosis of asthma, or
- At least one acute inpatient claim/encounter with asthma as the principal diagnosis or at least four outpatient visits with an asthma diagnosis and at least or
- At least four asthma four outpatient visit with an asthma diagnosis and at least two asthma medications dispensed, or
- At least four asthma medications dispensed in the last 12 month
Exclusion Criteria:
- Does not meet eligibility criteria for weight and/or asthma;
- Currently enrolled in another investigational asthma management /education/weight management trial.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Standard Control
Teens in the control group will receive standard or usual care as provided by their physician.
|
Teens in the control group will receive standard or usual care as provided by their physician.
|
|
Outro: Intervention
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
|
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Asthma Control Test
Prazo: 12 months of enrollment
|
A validated measure of asthma control
|
12 months of enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Mass Index (BMI)
Prazo: 12 months of enrollment
|
changes in participant weight
|
12 months of enrollment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christine Joseph, PhD, Henry Ford Health System
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
- 8298 (CTEP)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .