Hospitalization at Home of Elderly Patients With Exacerbated COPD

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00369083
First received: August 28, 2006
Last updated: NA
Last verified: January 2004
History: No changes posted
  Purpose

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).


Condition Intervention
COPD Exacerbation
Procedure: Hospital at home treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Home Hospitalizationfor Elderly Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • Mortality
  • Hospital readmissions at six months

Secondary Outcome Measures:
  • Length of hospital admission
  • Caregiver stress
  • Costs
  • Patient's quality of life

Estimated Enrollment: 100
Study Start Date: April 2004
Estimated Study Completion Date: October 2005
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  = 0.05 and a power 1-  = 0.8 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 patient’s 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 pneumologist’s 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 1:1 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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Exacerbation of COPD
  • Age >= 75 years
  • Living in hospital catchment area
  • Informed consent
  • Adequate social or familial support

Exclusion Criteria:

  • Patients requiring assisted ventilation or intensive monitoring
  • History of dementia
  • Severe renal or hepatic failure
  • Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369083

Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Investigators
Principal Investigator: Nicoletta Aimonino Ricauda, MD San Giovanni Battista Hospital, Torino
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00369083     History of Changes
Other Study ID Numbers: 515
Study First Received: August 28, 2006
Last Updated: August 28, 2006
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera San Giovanni Battista:
Frail elderly
Hospital at home

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014