NCT02571582

Brief Summary

Advanced Pulmonary Disease (PAD) is a condition that affects countless individuals around the world. Patients are often functionally very limited, with premature death, which is due to the disease itself or its complications. Currently, there are numerous monitoring centers of these patients to increase survival, reduce costs and humanize care in these patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
553

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

6.7 years

First QC Date

October 6, 2015

Last Update Submit

October 6, 2015

Conditions

Keywords

Predictors of mortality

Outcome Measures

Primary Outcomes (1)

  • Determine the predictors of mortality in patients with DPA in use of ODP

    Evaluate the results of evaluations carried out in patients who died and had advanced lung disease diagnosis in use of home oxygen, compared to patients who did not die and the normal population

    6 years

Secondary Outcomes (2)

  • Assess adherence to the use of home oxygen and its relation to the survival of these patients;

    6 years

  • To evaluate the influence of quality of life in patient survival;

    6 years

Other Outcomes (1)

  • Identify the causes of mortality of these patients.

    6 years

Study Arms (2)

Patients died

All patients underwent extensive evaluation: \- Body composition, Diabetes; dyslipidemia, hemoconcentration, hypertension, exercise capacity: 6-Minute Walk test procedure, renal function, inflammatory markers, cause and place of death, time tracking concentrator, quality of life and pulmonary Function.

living patients

All patients underwent extensive evaluation: \- Body composition, Diabetes; dyslipidemia, hemoconcentration, hypertension, exercise capacity: 6-Minute Walk test procedure, renal function, inflammatory markers, cause and place of death, time tracking concentrator, quality of life and pulmonary Function.

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Patients with established diagnosis of advanced lung disease that makes / made long home Oxygen use which were accompanied or followed at Oxygen Therapy Clinic of the Federal University of Uberlândia (UFU) by the Home Care Program (PAD), from 2009 to 2015. The sampling is for convenience.

You may qualify if:

  • Advanced Pulmonary disease using home oxygen therapy;
  • Have a diagnosis of chronic hypoxemia proven by blood gas analysis on room air PaO 2 ≤ 55 mm Hg or SaO2 ≤ 88; or PaO2 between 55 and 60 mmHg or SaO2 between 89 and 90%, with evidence of pulmonary hypertension, or polycythemia (hematocrit\> 55%) as GOLD - Global Obstructive Lung Disease, 2015;

You may not qualify if:

  • No records found Patients who failed to perform the periodic reviews established by the team responsible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Holmes DR Jr, Dehmer GJ, Kaul S, Leifer D, O'Gara PT, Stein CM. ACCF/AHA clopidogrel clinical alert: approaches to the FDA "boxed warning": a report of the American College of Cardiology Foundation Task Force on clinical expert consensus documents and the American Heart Association endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2010 Jul 20;56(4):321-41. doi: 10.1016/j.jacc.2010.05.013. No abstract available.

  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  • Tomioka K, Iwamoto J, Saeki K, Okamoto N. Reliability and validity of the International Physical Activity Questionnaire (IPAQ) in elderly adults: the Fujiwara-kyo Study. J Epidemiol. 2011;21(6):459-65. doi: 10.2188/jea.je20110003. Epub 2011 Sep 24.

  • Shah T, Jagpal S, Beckford R. Long-acting bronchodilators in patients with chronic obstructive pulmonary disease: still more to know. Ann Am Thorac Soc. 2014 Nov;11(9):1504. doi: 10.1513/AnnalsATS.201409-439LE. No abstract available.

  • Kim AL, Kwon JC, Park I, Kim JN, Kim JM, Jeong BN, Yu SK, Lee BK, Kim YJ. Reference equations for the six-minute walk distance in healthy korean adults, aged 22-59 years. Tuberc Respir Dis (Seoul). 2014 Jun;76(6):269-75. doi: 10.4046/trd.2014.76.6.269. Epub 2014 Jun 28.

  • Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

  • Velloso M, Jardim JR. Functionality of patients with chronic obstructive pulmonary disease: energy conservation techniques. J Bras Pneumol. 2006 Nov-Dec;32(6):580-6. doi: 10.1590/s1806-37132006000600017. English, Portuguese.

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vinícius Oliveira, Pafume

    Federal Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

January 1, 2009

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 8, 2015

Record last verified: 2015-10