- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01128348
A Patient Advocate and Literacy-Based Treatment of Asthma (HAP)
Visão geral do estudo
Descrição detalhada
This application addresses broad Challenge Area (05), Comparative Effectiveness Research, and Specific Challenge Topic 05-MD105, Health Literacy. Half of US adults have no more than basic reading and numerical skills; inadequate health literacy is a consequence. It is associated with unsatisfactory patient-provider communication and poor health outcomes in chronic diseases including asthma. We found low numeracy to be associated with prior ED visits and hospitalizations for asthma and determined that numerical skill may attenuate the association of minority status with lower asthma-related quality of life. We propose a Patient Advocate Intervention (PAI) as the most practical immediate but sustainable method of achieving effective health literacy (EHL) (understanding of asthma management and the practice/health system). Adapted from the Patient Navigator of Harold P. Freeman, MD and informed by focus groups of asthma patients, the PAI addresses low literacy, facilitating patient-provider communication surrounding self-management and navigation of the practice and health system to ensure medical recommendations can be accomplished. The PA is a nonprofessional with guidance from a social worker who will assist with and model preparations for a visit with the asthma doctor, attend the visit, and afterwards confirm understanding as well as facilitate scheduling, obtaining insurance coverage, and overcoming other barriers to carrying out medical advice. The primary outcome is electronically-monitored use of inhaled corticosteroids (ICS), the treatment of choice for all but the mildest asthma. ICS use is a marker of successful patient-provider communication. Other outcomes are asthma-related: hospitalizations, ED visits, change in FEV1, and asthma-related quality of life. We hypothesize that the PAI will improve these outcomes by promoting EHL.
We will enroll 84 adults with a high prevalence of low numerical skills who are approximately 67% black and 10% Latino with moderate or severe asthma to carry out the following Specific Aims. Specific Aim 1: refine and evaluate the feasibility of PAI and Specific Aim 2: conduct a randomized comparison of PAI with standard asthma education to obtain effect size estimates for ICS adherence and asthma-related outcomes for a future R01 confirmatory randomized trial of the final version of PAI. Exploratory analyses will assess EHL as a mediator, various moderators, and estimate the incremental costs of PAI. This novel project fills several research gaps. It 1) compares and tests an intervention addressing literacy to improve health, one that can easily be incorporated into practice to better patient self-management and preventive care, 2) is a potentially long-lasting intervention which will benefit all patients, especially those with low health literacy, and 3) will potentially improve prevention of asthma exacerbations, reducing the need for ED use.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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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:
- physician's diagnosis of asthma
- prescribed inhaled steroid
- moderate or severe asthma according to NHLBI Guidelines
- evidence of reversible airflow obstruction and improvement with bronchodilator
- Did not participate in the experimental arm (problem-solving) of WIN Study, HL073932
Exclusion Criteria:
- significant other current pulmonary or cardiac disease
- severe psychiatric problems making it impossible to understand or carryout the protocol
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: patient advocate
Patient advocate works with patient before, during, and after a visit to asthma doctor. Patient receives video of asthma education materials |
patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
|
Comparador Ativo: asthma education
Patient receives video of asthma education materials
|
patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
adherence to prescribed inhaled corticosteroid regimen
Prazo: 16 weeks
|
16 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
change in FEV1
Prazo: 16 weeks
|
16 weeks
|
asthma-related quality of life
Prazo: 16 weeks
|
16 weeks
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asthma control
Prazo: 16 weeks
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16 weeks
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emergency department visits for asthma
Prazo: 16 weeks
|
16 weeks
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hospitalizations for asthma
Prazo: 16 weeks
|
16 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andrea J Apter, MD, MSc, MA, University of Pennsylvania
Publicações e links úteis
Publicações Gerais
- Black HL, Priolo C, Gonzalez R, Geer S, Adam B, Apter AJ. An analysis of contextual information relevant to medical care unexpectedly volunteered to researchers by asthma patients. J Asthma. 2012 Sep;49(7):731-7. doi: 10.3109/02770903.2012.699988. Epub 2012 Jul 13.
- Black HL, Priolo C, Akinyemi D, Gonzalez R, Jackson DS, Garcia L, George M, Apter AJ. Clearing clinical barriers: enhancing social support using a patient navigator for asthma care. J Asthma. 2010 Oct;47(8):913-9. doi: 10.3109/02770903.2010.506681.
- Krishnan JA, Schatz M, Apter AJ. A call for action: Comparative effectiveness research in asthma. J Allergy Clin Immunol. 2011 Jan;127(1):123-7. doi: 10.1016/j.jaci.2010.08.032. Epub 2010 Sep 19.
- Apter AJ, Wang X, Bogen DK, Rand CS, McElligott S, Polsky D, Gonzalez R, Priolo C, Adam B, Geer S, Ten Have T. Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Sep;128(3):516-23.e1-5. doi: 10.1016/j.jaci.2011.05.010. Epub 2011 Jun 25.
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 (Estimativa)
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
- 700
- RC1HL099612 (Concessão/Contrato do NIH dos EUA)
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