COPDEXADOMNCT03474575
Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of COPD
A study testing Prevention in people with COPD, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2017to 19 Dec 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Current or former smoker, with at least 10 pack-years
- previous history of COPD with concordant spirometry results
- Admission to the emergency department for an exacerbation defined as an acute event which is characterized by a degradation of respiratory symptoms greater than the usual daily variations and requiring a change in therapeutic management
- Patient with mild exacerbation characterized by a DECAF score at 0 or 1. (DECAF score: Dyspnea, Eosinopenia, Consolidation on chest x-ray, Acidaemia, and atrial Fibrillation. One point for each criterion. Mortality at one month is less than 3% if the DECAF score is 0 or 1).
- Residence within 30km of Grenoble Alps University Hospital
- Patient legally able to give consent
- Person affiliated to a medical insurance
Who cannot join
- Dementia or non-communicating patient in French language
- Patient unable to call the emergency department at any time in case of sudden worsening
- Pregnancy or breastfeeding woman
- patient under administrative or judicial supervision
- DECAF Score > 1. Patient's with DECAF score > 1 are considered at too high risk of mortality to be managed at home (they are usually hospitalized).
Trial locations and contacts
1 site in 1 country.
France1 site
Emergency Department of University Hospital Grenoble
Grenoble, Auvergne Rhonalpes, 38043
About this study
Official title: EXADOM: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. The evolution of COPD is marked by the occurrence of exacerbations of varying severity responsible for 1% of emergency department admission. Thus,95% of COPD patients admitted to emergency department for exacerbation are hospitalized.
Several recent studies seem to show that an early discharge from hospital with home care can reduce the rate of rehospitalisation and mortality of COPD patients. These preliminary data on low numbers need to be confirmed. In addition, it seems necessary to identify the phenotypes of patients who benefit most from these early exits.
Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS), AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging patients by providing enhanced home-based care for AECOPD.
Read the detailed description
Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS) , Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.
This program implements ambulatory care immediately after leaving the emergency department with a main goal of reducing hospital readmission during the first month. The home-based support includes daily visits at home conducted by the home care provider's nurses from day 1 to day 7, telephone calls at days 14 and 21 and a final home visit one month after discharge from the emergency department. Blood samples will be collected at inclusion, day 7 and one month during home visit and urine samples at inclusion, day 2, day 4 and one month during home visit .Telephone follow-up at 3, 6 months and one year.
- Conditions
- COPD
- Being tested
- Prevention
- Keywords
- homecare, COPD, Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreventionOther
The purpose is to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.
| Study group | Role | What they receive |
|---|---|---|
| COPD patient | Other | Prevention of re-hospitalization rate for Early supported discharge and enhanced homecare to patient admited for COPD exacerbation Receives: Other: Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hospitalizations
number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay
Measured: 90 days
Secondary outcomes (8)
Rate of all cause of hospitalizations
number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for all cause
Measured: 6 months and one year
hospitalization rate for COPD exacerbation aggravation
number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay for COPD exacerbation aggravation
Measured: 3,6 and 12 months
Hospitalization rate for worsening for cardio-respiratory symptoms
number of hospitalizations due to myocardial infarction, cardiac failure, stroke
Measured: one year
Mortality
number of death
Measured: 3, 6 and 12 months
Determinants of hospitalization
measures of biological and clinical markers collected at baseline and at day 30
Measured: 30 days
Differential of biological and clinical markers
Differential measurements of biological and clinical markers between day 30 and at inclusion
Measured: 30 days
Differential of medical average cost per patient
comparaison between early discharge patient with ambulatory care group and patient with standard care (historical cohort)
Measured: 3 months
Acceptance rate of early ambulatory care
Measured on the basis of a refusal register
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start19 May 2017
- Primary completion28 Oct 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective and Biomedical Research excluding Health Product
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- AGIR à Dom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474575
- Sponsor's protocol ID
- 38RC16.275
- Acronym
- EXADOM
- Status last verified
- May 2024
- First submitted
- 9 Feb 2018
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not provided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXADOM: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03474575
- Acronym / sponsor ID
- EXADOM / 38RC16.275
- Conditions
- COPD
- Keywords
- homecare, COPD, Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- AGIR à Dom
- Study start
- 19 May 2017 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 22 Mar 2018 (actual)
- 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.
The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. The evolution of COPD is marked by the occurrence of exacerbations of varying severity responsible for 1% of emergency department admission. Thus,95% of COPD patients admitted to emergency department for exacerbation are hospitalized.
Several recent studies seem to show that an early discharge from hospital with home care can reduce the rate of rehospitalisation and mortality of COPD patients. These preliminary data on low numbers need to be confirmed. In addition, it seems necessary to identify the phenotypes of patients who benefit most from these early exits.
Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS), AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging patients by providing enhanced home-based care for AECOPD.
Detailed description
Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS) , Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.
This program implements ambulatory care immediately after leaving the emergency department with a main goal of reducing hospital readmission during the first month. The home-based support includes daily visits at home conducted by the home care provider's nurses from day 1 to day 7, telephone calls at days 14 and 21 and a final home visit one month after discharge from the emergency department. Blood samples will be collected at inclusion, day 7 and one month during home visit and urine samples at inclusion, day 2, day 4 and one month during home visit .Telephone follow-up at 3, 6 months and one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective and Biomedical Research excluding Health Product
| Arm | Type | Receives |
|---|---|---|
| COPD patient | Other | Other: PreventionPrevention of re-hospitalization rate for Early supported discharge and enhanced homecare to patient admited for COPD exacerbation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 40 years
- Current or former smoker, with at least 10 pack-years
- previous history of COPD with concordant spirometry results
- Admission to the emergency department for an exacerbation defined as an acute event which is characterized by a degradation of respiratory symptoms greater than the usual daily variations and requiring a change in therapeutic management
- Patient with mild exacerbation characterized by a DECAF score at 0 or 1. (DECAF score: Dyspnea, Eosinopenia, Consolidation on chest x-ray, Acidaemia, and atrial Fibrillation. One point for each criterion. Mortality at one month is less than 3% if the DECAF score is 0 or 1).
Key exclusion criteria (5 listed)
- Dementia or non-communicating patient in French language
- Patient unable to call the emergency department at any time in case of sudden worsening
- Pregnancy or breastfeeding woman
- patient under administrative or judicial supervision
- DECAF Score > 1. Patient's with DECAF score > 1 are considered at too high risk of mortality to be managed at home (they are usually hospitalized).
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 |
|---|---|---|
| PreventionThe purpose is to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care. | Other | COPD patient |
Primary outcome
Rate of hospitalizations
Time frame: 90 days
number of an hospitalization being an entry in any hospital or clinic , whatever the length of the stay
8 secondary outcomes
Rate of all cause of hospitalizations
Time frame: 6 months and one year
hospitalization rate for COPD exacerbation aggravation
Time frame: 3,6 and 12 months
Hospitalization rate for worsening for cardio-respiratory symptoms
Time frame: one year
Mortality
Time frame: 3, 6 and 12 months
Determinants of hospitalization
Time frame: 30 days
Differential of biological and clinical markers
Time frame: 30 days
Differential of medical average cost per patient
Time frame: 3 months
Acceptance rate of early ambulatory care
Time frame: 1 year
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 14 May 2024.
- Individual participant dataSharing planned: No. Not provided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention in people with COPD, run by University Hospital, Grenoble at 1 site in France.
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 8 inclusion and 5 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Rate of hospitalizations (time frame: 90 days). 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 14 May 2024.