Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369083
Status:
COMPLETED
Last Update Posted:
2006-08-29
First Post:
2006-08-28
Brief Title:
Hospitalization at Home of Elderly Patients With Exacerbated COPD
Sponsor:
Azienda Ospedaliera San Giovanni Battista
Organization:
Azienda Ospedaliera San Giovanni Battista
Study Overview
Official Title:
Home Hospitalizationfor Elderly Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2004-01
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:
Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with inpatient care in selected elderly patients with acute exacerbation of chronic obstructive pulmonary disease COPD
Detailed Description:
A total of 104 patients with an exacerbation of chronic obstructive pulmonary disease COPD selected from the Emergency Department ED of the hospital were randomized to home treatment from a Geriatric Home Hospitalization Service GHHS or to General Medical Ward GMW
The sample size estimation was performed according to the increasing 1-year June 2002-May 2003 incidence of COPD exacerbation in hospital at home On this basis al least 100 patients needed to be included in the study to allow to detect a 20 difference in the endpoint hospital iatrogenic diseases with a statistical significance 005 and a power 1- 08 using a two-sided test
This study is considered a single-blind study because patients were aware of the treatment assignment while physicians and nurses evaluating patients were blinded to the patients allocation
In the ED all patients underwent baseline standard clinical evaluation blood tests blood cell count routine biochemical tests and arterial blood gas tensions pulse oximetry 12-lead electrocardiography chest radiographs and hand-held spirometry SpirHOMEter COSMED Italy Further investigations including pneumologists assessment were performed when required according to the clinical judgement of the ED physician Only patients with a COPD exacerbation evaluated in ED for at least 12-24 hours and with stable clinical conditions were considered elegible to be included in the study
Additional exclusion criteria were 1 living outside the hospital catchment area 2 absence of family and social support 3 absence of informed consent 4 necessity of intensive monitoring or mechanical ventilation 5 history of dementia 6 severe renal or hepatic failure 7 cancer
Patients fullfilling inclusion criteria were informed about the nature of the study and asked to give their informed consent Extensive information was also provided to patients relatives to obtain their collaboration Patients fullfilling the inclusion criteria and having none of the criteria for exclusion were randomised using a set of computer-generated random numbers in a 11 ratio either to the treatment group home-based hospitalization GHHS or to the control group conventional care GMW using blinded sealed envelopes Intention-to-treat analysis was used
The sample size estimation was performed according to the increasing 1-year June 2002-May 2003 incidence of COPD exacerbation in hospital at home On this basis al least 100 patients needed to be included in the study to allow to detect a 20 difference in the endpoint hospital iatrogenic diseases with a statistical significance 005 and a power 1- 08 using a two-sided test
This study is considered a single-blind study because patients were aware of the treatment assignment while physicians and nurses evaluating patients were blinded to the patients allocation
In the ED all patients underwent baseline standard clinical evaluation blood tests blood cell count routine biochemical tests and arterial blood gas tensions pulse oximetry 12-lead electrocardiography chest radiographs and hand-held spirometry SpirHOMEter COSMED Italy Further investigations including pneumologists assessment were performed when required according to the clinical judgement of the ED physician Only patients with a COPD exacerbation evaluated in ED for at least 12-24 hours and with stable clinical conditions were considered elegible to be included in the study
Additional exclusion criteria were 1 living outside the hospital catchment area 2 absence of family and social support 3 absence of informed consent 4 necessity of intensive monitoring or mechanical ventilation 5 history of dementia 6 severe renal or hepatic failure 7 cancer
Patients fullfilling inclusion criteria were informed about the nature of the study and asked to give their informed consent Extensive information was also provided to patients relatives to obtain their collaboration Patients fullfilling the inclusion criteria and having none of the criteria for exclusion were randomised using a set of computer-generated random numbers in a 11 ratio either to the treatment group home-based hospitalization GHHS or to the control group conventional care GMW using blinded sealed envelopes Intention-to-treat analysis was used
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