- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01935726
Pulmonary Fibrosis Contact Registry
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Colorado
-
Denver, Colorado, Verenigde Staten, 80206
- National Jewish Health Interstitial Lung Disease Program
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Ander
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
|---|
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number enrolled
Tijdsspanne: 20 years
|
This is a contact registry.
We will enroll as many patients and primary supporters/caretakers as possible.
|
20 years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jeff Swigris, DO, MS, National Jewish Health
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PCORI 4134
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .