- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01935726
Pulmonary Fibrosis Contact Registry
Visão geral do estudo
Status
Descrição detalhada
Detailed information can be found at our website at www.pulmonaryfirbrosisresearch.org.
Who will be in the Registry?
Anyone who is at least 18 years of age, can read and understand English, and either
- diagnosed with PF or
- a primary supporter or caregiver of someone living with PF
How the Registry works
Patients with PF consent to be enrolled in the Registry and may consent to be contacted by Registry personnel about opportunities for them to participate in research studies. Some of these studies (e.g., "Observing the Effects of Supplemental Oxygen on Patients with Pulmonary Fibrosis") will be conducted by Dr. Swigris and his research team-these studies will be considered Registry-affiliated. Registry participants are free to enroll in any study they wish-whether Registry-affiliated or conducted by investigators not affiliated with the Registry-i.e., non-Registry-affiliated studies. It is assumed the investigators conducting those studies will adhere to regulations governing the protection of human subjects in research. Consider a hypothetical example: an investigator in Michigan is conducting a study of the effects of oral honey on PF-related cough and would like Registry participants to consider enrollment. The investigator would petition the Registry and, if approved by the Registry Oversight Committee, Registry personnel would contact potentially eligible Registry participants to inform them of the study. The participants would then decide whether or not to contact the investigator in Michigan to be considered for enrollment. The investigatory in Michigan would be responsible for discussing the study with any potential subject, obtaining informed consent and conducting the study. All of these fall outside the purview of the Registry or its personnel.
How subjects will enroll in the Registry
Eligible participants must fill out an intake questionnaire/consent form. Contact information provided to receive a questionnaire is not stored by the Registry Data Coordinating Center (DCC) or by the study coordinator. Subjects may obtain the intake questionnaire, complete it, and submit it four different ways:
- Complete the questionnaire/consent form and submit it online at https://dccweb.njhealth.org/sec/P3F_Swigris/Index.htm. Participants will be encouraged to print a copy for their records.
- Enter a mailing address onto an online form at http://pulmonaryfibrosisresearch.org/contact and have a hard copy mailed to the subject. Once a signed questionnaire/consent has been sent back to the study coordinator, a copy will be made and mailed back to the participant for his/her records.
- Fill out the form electronically at https://dccweb.njhealth.org/sec/P3F_Swigris/Index.htm and print a copy of the form, or print the form and fill it out by hand and mail or fax the completed questionnaire to the study coordinator who will then hand it off to the DCC at National Jewish Health. Participants will be encouraged to print a copy for their records.
- Call the study coordinator toll-free at 1-855-609-0010 and have him/her mail a hard copy of the questionnaire/consent form to the subject. Once a signed questionnaire/consent has been sent back to the study coordinator, a copy will be made and mailed back to the participant for his/her records.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
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Colorado
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Denver, Colorado, Estados Unidos, 80206
- National Jewish Health Interstitial Lung Disease Program
-
-
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:
- Anyone who self-reports a diagnosis of pulmonary fibrosis and is over 18 years of age will be included in the Registry.
- Anyone who self-reports being a primary supporter or caregiver of someone living with pulmonary fibrosis and is over the age of 18 will be included in the Registry.
- Whoever consents to be enrolled in the Registry will presumably be able to read and write in English.
Exclusion Criteria:
- Failure to meet inclusion criteria
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Outro
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Pulmonary fibrosis patients or their caretaker/supporter
Patients with pulmonary fibrosis of any cause (idiopathic, related to connective tissue disease [e.g., rheumatoid arthritis, systemic sclerosis/scleroderma, dermato-/polymyositis, sjogren's syndrome], familial or genetic) or the primary supporter/caregiver of a patient with pulmonary fibrosis
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number enrolled
Prazo: 20 years
|
This is a contact registry.
We will enroll as many patients and primary supporters/caretakers as possible.
|
20 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeff Swigris, DO, MS, National Jewish Health
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
- PCORI 4134
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 .