DiedPUFPAENCT02852733
Better Understand End-of-life Emergencies' Management Among Elderly in Nursing Homes: a Pilot Study in Brittany, France
An observational study of Died and in End-of-life Situation, run by Rennes University Hospital at 1 site in France.
Trial summary
The purposes of this study are : To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes. To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Died, in End-of-life Situation
- What is being tested?
- end-of-life emergencies' management
- How many people
- 602 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Jun 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Résidents of 150 nursing homes randomly selected in Brittany
Who may be able to join
- dead residents during the quarter preceding the date of the Survey Or
- Residents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of "terminal condition" contained in the guide of the CNSA (coding PATHOS - April 2011)).
Who cannot join
- patients opposing the study,
- patients aged below 18 year old
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of this study are :
- To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes.
- To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use.
- To know and to understand the practical and organizational elements, in nursing homes, that can determine a (re) hospitalization or an end-of-life
- Conditions
- Died, in End-of-life Situation
- Being tested
- end-of-life emergencies' management
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
end-of-life emergencies' managementOther
| Study group | Role | What they receive |
|---|---|---|
| Residents in end-of-life situation | Residents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of "terminal condition" contained in the guide of the CNSA (coding PATHOS - April 2011)). Receives: Other: end-of-life emergencies' management | |
| dead residents | dead residents in the quarter preceding the date of the survey Receives: Other: end-of-life emergencies' management |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of end-of-life emergencies' episodes
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiedStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francoise FR RIOU, MD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852733
- Sponsor's protocol ID
- 35RC12_8988
- Acronym
- PUFPAE
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Understand End-of-life Emergencies' Management Among Elderly in Nursing Homes: a Pilot Study in Brittany, France
- ClinicalTrials.gov ID
- NCT02852733
- Acronym / sponsor ID
- PUFPAE / 35RC12_8988
- Conditions
- Died, in End-of-life Situation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Aug 2016 (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.
The purposes of this study are :
- To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes.
- To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use.
- To know and to understand the practical and organizational elements, in nursing homes, that can determine a (re) hospitalization or an end-of-life
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residents in end-of-life situation | – | Other: end-of-life emergencies' managementResidents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of "terminal condition" contained in the guide of the CNSA (coding PATHOS - April 2011)). |
| dead residents | – | Other: end-of-life emergencies' managementdead residents in the quarter preceding the date of the survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Résidents of 150 nursing homes randomly selected in Brittany
Key inclusion criteria (2 listed)
- dead residents during the quarter preceding the date of the Survey Or
- Residents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of "terminal condition" contained in the guide of the CNSA (coding PATHOS - April 2011)).
Key exclusion criteria (2 listed)
- patients opposing the study,
- patients aged below 18 year old
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 |
|---|---|---|
| end-of-life emergencies' management | Other | Residents in end-of-life situation, dead residents |
Primary outcome
number of end-of-life emergencies' episodes
Time frame: through study completion, an average of 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 2 Aug 2016.
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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.
Francoise FR RIOU, MD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Died and in End-of-life Situation, run by Rennes University Hospital 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 2 inclusion and 2 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 2 Aug 2016. 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?
number of end-of-life emergencies' episodes (time frame: through study completion, an average of 1 year). 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 2 Aug 2016.