Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129779
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2005-08-11
Brief Title:
Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients With COPD
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
A Randomised Control Trial Assessing the Effects of an Intermediate Care Package in Preventing Hospitalisation of Elderly Patients With Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic obstructive pulmonary disease COPD is a term used for the conditions of chronic bronchitis and emphysema diseases that are very common among the elderly and diseases that account for up to15 of all general medical admissions to National Health Service Hospitals In a recent report on emergency admissions to acute hospitals in London the Kings Fund concluded that taking better care of elderly patients with COPD could reduce pressures on acute hospitals and suggested that identification of vulnerable patients with lung disease and pro-active rather than reactive management might reduce the chances of hospitalisation In this study the investigators wish to compare a group of patients with COPD who are managed in the normal way with another group of patients with COPD who receive all interventions known to be of some benefit to those with this condition This will include a pulmonary rehabilitation programme intensive education regarding self care targeted advice to their general practitioners regarding how best to manage COPD and regular contact with specialist respiratory nurses who will support the patients in their own homes by a combination of home visits and telephone contact The value of such a comprehensive intervention will be studied in terms of both its ability to reduce admissions to the hospital and its impact on quality of life
Detailed Description:
One hundred twenty-two patients over the age of 50 with COPD admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of their condition will be recruited and randomised to routine and opportunistic care n 61 vs study care package n61 for 2 years The patients randomised to the study package will take part in an initial pulmonary rehabilitation programme of 8 sessions of physical therapy and education 2 sessions a week for 4 weeks Health related quality of life will be measured in the intervention and routine care groups using validated instruments SF-36 and Canadian Respiratory Diseases Questionnaire This will be followed by a baseline home visit and assessment from an experienced specialist respiratory nurse Grade G followed by monthly telephone calls and a home visit every 3 months Each interview and visit will be a structured intervention addressing specific issues related to the management of COPD with four possible specific outcomes including history taking measurement of vital signs discussion of treatment appropriate vaccination and discussing and reinforcing self-management education At the end of the 2 year study period the routine care and intervention groups will be compared for the following outcomes number of admissions to hospital for exacerbations of COPD number of unplanned visits to a general practitioner with those initiated by study nurse identified separately measures of quality of life SF-36 CRDQ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None