NCT01948544

Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease

A Study to Evaluate Improvement in the Quality of Life and Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: StratiHealth · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

* Evaluate subjects in an prospective observational study * Subjects will be administered scientifically validated questionnaires * Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in: 1. Exercise capability, dyspnea and quality of life as primary endpoints 2. Utilize: 1. Baseline Dyspnea Index (BDI) 2. Transitional Dyspnea Index (TDI) 3. Chronic Respiratory Disease Questionnaire (CRQ) 4. Six minute walk test (6MWT) 5. Epworth Sleepiness Scale (ESS) * The secondary endpoints will be: 1. Rate of exacerbations, sleep quality 2. Health care utilization (emergency room encounters, hospital admissions)

Detailed description

Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the affect of the Portable Oxygen Concentrator on improvements in exercise capability, dyspnea and quality of life as primary endpoints, utilizing the Baseline Dyspnea Index (BDI), Transitional Dyspnea Index (TDI), the Chronic Respiratory Disease Questionnaire (CRQ) and six minute walk test (6MWT). The secondary endpoints will be rate of exacerbations, sleep quality (reported as number of hours sleep improvement; utilize Epworth Sleepiness Scale \[ESS\]), and health care utilization (emergency room encounters, hospital admissions).

Conditions

• COPD

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-09-23
• Last updated: 2018-08-20

Locations

3 sites across 1 country: United States