- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00784342
Validation of PROMIS Banks With COPD Exacerbations
Visão geral do estudo
Status
Condições
Descrição detalhada
This is a prospective longitudinal study of adult patients with chronic obstructive pulmonary disease (COPD) who will be enrolled when their COPD is considered clinically stable or during an acute exacerbation. This design will allow both within-person and between-person comparisons by exacerbation experience. Comprehensive clinical and patient-reported assessments will be performed at baseline and at 3 months (end of study). Subsets of items will be administered by interactive voice response (IVR) over the course of the study to measure changes in key symptoms over the course of recovery from an exacerbation. A subset of patients will be interviewed at the end of the study to assess content validity of PROMIS items in this patient population.
With such a study design, we will be able to evaluate the validity of the PROMIS items in this patient population under acute and stable conditions and evaluate responsiveness of several PROMIS item banks under conditions of known change in an underlying chronic disease. We will also evaluate stability of sub-domains that are not hypothesized to change with COPD exacerbations.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- NorthShore University HealthSystem (Formerly Evanston Northwestern Healthcare)
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, Estados Unidos, 27701
- Duke University
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15261
- University of Pittsburgh
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Pittsburgh, Pennsylvania, Estados Unidos, 15240
- Pittsburgh VA Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- An established clinical history of COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) definition: COPD is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.
- A history of smoking (at least 10 pack/year history)
- Access to and able to communicate on a touch tone telephone
- Read and speak English
- Able to see and interact with a computer screen, mouse, and keyboard
- A signed and dated written informed consent prior to study participation
- For those enrolled into the exacerbation group: Treatment for an exacerbation may have been started no more than 3 days prior to the day of enrollment for patients recruited in the outpatient setting and no more than 6 days prior to the day of enrollment for patients recruited in the in-patients setting.
- For those enrolled in the stable state group, the patient will be considered stable if he or she has been exacerbation-free for a minimum of 2 months prior to enrollment.
Exclusion Criteria:
- Any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render the participant unable to complete a questionnaire)
- History of asthma without co-existent COPD as the primary diagnosis
- Experiencing a current heart failure exacerbation. (A diagnosis of heart failure is not in itself an exclusion criterion.)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Stable
Patients who are stable have not had a COPD exacerbation in the past 2 months.
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Exacerbation
Patients with an exacerbation have been diagnosed and started on treatment for an exacerbation within the past 3 days.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Darren A. Dewalt, MD, MPH, University of North Carolina, Chapel Hill
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
- 07-02
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