COPD ExacerbationNCT00369083
Hospitalization at Home of Elderly Patients With Exacerbated COPD
A study testing Hospital at home treatment in people with COPD Exacerbation, run by Azienda Ospedaliera San Giovanni Battista.
Trial 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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Hospital at home treatment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Exacerbation of COPD
- Age >= 75 years
- Living in hospital catchment area
- Informed consent
- Adequate social or familial support
Who cannot join
- Patients requiring assisted ventilation or intensive monitoring
- History of dementia
- Severe renal or hepatic failure
- Cancer
About this study
Official title: Home Hospitalizationfor Elderly Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a Randomized Controlled Trial.
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).
Read the 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.
- Conditions
- COPD Exacerbation
- Being tested
- Hospital at home treatment
- Keywords
- Frail elderly, Hospital at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital at home treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Hospital readmissions at six months
Secondary outcomes (4)
Length of hospital admission
Caregiver stress
Costs
Patient's quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startApr 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Investigators
- Nicoletta Aimonino Ricauda, MD, Principal investigator, San Giovanni Battista Hospital, Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369083
- Sponsor's protocol ID
- 515
- Status last verified
- Jan 2004
- First submitted
- 28 Aug 2006
- Last updated
- 29 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Hospitalizationfor Elderly Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00369083
- Acronym / sponsor ID
- 515
- Conditions
- COPD Exacerbation
- Keywords
- Frail elderly, Hospital at home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2005
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 = 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Exacerbation of COPD
- Age >= 75 years
- Living in hospital catchment area
- Informed consent
- Adequate social or familial support
Key exclusion criteria (4 listed)
- Patients requiring assisted ventilation or intensive monitoring
- History of dementia
- Severe renal or hepatic failure
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital at home treatment | Procedure or surgery | – |
Primary outcome
Mortality
Hospital readmissions at six months
4 secondary outcomes
Length of hospital admission
Caregiver stress
Costs
Patient's quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2006.
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FreeDom: Innovative Strategy for the Management of COPD Exacerbations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicoletta Aimonino Ricauda, MD principal investigator
San Giovanni Battista Hospital, Torino
Questions about this trial
What is this clinical trial studying?
A study testing Hospital at home treatment in people with COPD Exacerbation, run by Azienda Ospedaliera San Giovanni Battista.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2006.