A prospective, randomised controlled, multi-center trial comparing in-hospital treatment and early assisted discharge for exacerbations of Chronic Obstructive Pulmonary Disease (COPD).
Completed
- Conditions
- COPD - chronic brochitis and pulmonary emphysema10006436
- Registration Number
- NL-OMON31318
- Lead Sponsor
- Zorgonderzoek Nederland (ZON)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 235
Inclusion Criteria
*>18 years an competent
*moderate/severe exacerbation of COPD
* written informed consent
Exclusion Criteria
* live-threated an clinically unstable condition
* major uncontrolled co-morbidity
* mental disability
* active alcoholism and drug abuse
* inability to understand the program
* living outside the region of care of home care organisation
* admission to the intensive care unit
* indication for NIPPV
* insufficient direct caregiver
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is the score on the CCQ measured on day 7. This score<br /><br>represents the change in health status.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are:<br /><br><br /><br>* number of treatment failures during the first week (patients that went on<br /><br>assissted discharge but their condition deteriorated requiring re-admission<br /><br>* health care utilization<br /><br>* costs<br /><br>* CCQ score at 3 months<br /><br>* 3-months re-admission rate<br /><br>* 3-months mortality rate<br /><br>* EQ-5D measured on day 7 and at 3 months<br /><br>* patient and caregiver satisfaction measured with a dutch translation of the<br /><br>COPD Project East Yorkshire Hospitals NHS Trust-Medical Chest Unit<br /><br>questionnaire.<br /><br><br /><br></p><br>