NCT03103178

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

March 23, 2017

Last Update Submit

March 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validation of a specific quality of life questionnaire for patients with ILD

    6 months

Interventions

Measurement of quality of life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Subjects older than 18 years.
  • Diagnosis of ILD, established according to the consensus documents of the ATS and ERS \[1,2\].
  • 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.

You may not qualify if:

  • Another chronic respiratory disease other than EPID.
  • Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

April 6, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

April 6, 2017

Record last verified: 2017-03

Locations