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Spanish Version of the KBILD Questionnaire

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103178
Recruitment Status : Unknown
Verified March 2017 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date March 23, 2017
First Posted Date April 6, 2017
Last Update Posted Date April 6, 2017
Actual Study Start Date January 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 31, 2017)
Validation of a specific quality of life questionnaire for patients with ILD [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spanish Version of the KBILD Questionnaire
Official Title Translation Into Spanish of an Interstitial Lung Disease Quality of Life Questionnaire (KBILD)
Brief Summary

The purpose of the present study is to advance in the knowledge of quality of life in patients with ILD by translating a ILD quality of life questionnaire.

There are no specific tools validated in Spanish to evaluate the quality of life in patients with ILD, although these measures are useful for an comprensive evaluation of these patients.

Patients with ILD have a significant impact on their health. If we improve our Knowledge of the different domains affected by the disease, and not only in the pathophysiological ones, we will be able to develop tools to improve their management.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects over 18 years of age diagnosed with diffuse interstitial lung disease for which they are being followed up at the respiratory department of the Santa Creu i Sant Pau Hospital.
Condition Pulmonary Fibrosis
Intervention Other: Quality of life questionnaire
Measurement of quality of life
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 31, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  1. Subjects older than 18 years.
  2. Diagnosis of ILD, established according to the consensus documents of the ATS and ERS [1,2].
  3. Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits.

Exclusion criteria

  1. Another chronic respiratory disease other than EPID.
  2. Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03103178
Other Study ID Numbers IIBSP-KBI-2016-47
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators Not Provided
Investigators Not Provided
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date March 2017