Practice Nurse's ScopePROPAGE2NCT04818684
Practices of Accompaniment of the Relatives of Patients in the AGonic Phase by an Interdisciplinary Team
An observational study of Practice Nurse's Scope, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The PROPAGE study program aims above all to improve the experience and satisfaction of family and friends regarding the support they receive during the dying person's agony phase. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Practice Nurse's Scope
- What is being tested?
- questionnaire
- How many people
- 278 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 15 May 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This includes people working in a palliative care unit as well as relatives who have known a patient in agony phase in a palliative care unit.
Who may be able to join
- PALLIATIVE CARE UNITS (USP) 35 palliative care unit will be drawn at random among the 164 French palliative care unit (www.sfap.org). In the event of refusal of participation, the drawing of lots will continue until 35 participating palliative care unit are obtained. The inclusion criteria for palliative care units were determined from the survey carried out in 2013 by the National End of Life Observatory on palliative care units in France. In order for there to be representativeness, the status of the palliative care unit will be taken into account from the national University Hospital (CHU) distribution, excluding CHU in the public sector, private non-profit sector, private for-profit sector. Thus, out of the 35 palliative care units: 7 will be within CHU, 16 will be outside CHU in the public sector, 7 will be in the private non-profit sector, and 5 in the private for-profit sector (criteria determined from the survey of the National End of Life Observatory in 2013) by ensuring that there are no more than 3 palliative care units in the same department (this in order to avoid that a geographical territory is over-represented, which would be liable to bias the results).
- In the event of refusal of a palliative care units or of inadequacy of the criteria, the drawing of lots will be continued until 35 participating USPs are obtained.
- Each team of these palliative care units must allow the participation of 7 experts: 1 for each group of experts, i.e. 5 socio-health professionals working in all the palliative care units (doctors, psychologists, nursing assistants, nurses, socio-educational assistant) as well as the coordinator of support volunteers and a relative by palliative care unit.
- THE EXPERTS
- 6 volunteer experts who will participate in the panel of voters: a doctor (group 1), an IDE ( group 2), an AS (group 3), a psychologist (group 4), an ASE (group 5), a volunteer support coordinator (group 6) . A relative (group 7) will be done.
- The inclusion criteria:
Show all 19Show fewer
- For professionals, at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit.
- For volunteers, at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. The representative participating in the study will preferably be the volunteer coordinator.
- For relatives Relative of a patient who died in the palliative care unit at least 6 months ago Person to trust or to prevent if not designated Relative understanding and speaking sufficient French Relative not a health professional
- Relative who visited the palliative care unit during the last 3 days of the patient's life and who met the care team:
- Traceability of the arrival of the loved one in the last 2/3 days of the patient's hospitalization
- Traceability of a meeting of the loved one with a member of the team over the last 3 days of his hospitalization or verification during telephone contact with the loved one after drawing lots Relative with an email address (to be verified during telephone contact with the loved one after drawing lots)
- NO-INCLUSION AND EXCLUSION CRITERIA
- PALLIATIVE CARE UNITS Palliative care unit who could not be represented by the 7 experts required
- Have participated in the PROPAGE 1 study
- Have taken part in the questionnaire test.
- THE EXPERTS Palliative care unit Experts: Anyone with less than 3 years of palliative care unit experience.
- Relatives:
- Relative of a patient who died in the palliative care unit less than 6 months ago Relative not understanding and not speaking French enough Relative being a health professional Relative who has not been to the palliative care unit in the last 3 days of the patient's life Relative who does not have an email address (to be checked during telephone contact with the loved one after drawing lots).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practices of Accompaniment of the Relatives of Patients in the Agonic Phase by an Interdisciplinary Team
The PROPAGE study program aims above all to improve the experience and satisfaction of family and friends regarding the support they receive during the dying person's agony phase.
Read the detailed description
The objective of PROPAGE 2 is to establish a consensus on the practices for accompanying relatives during the agonic phase in the context of hospitalization in the palliative care unit by an interdisciplinary team.
- Conditions
- Practice Nurse's Scope
- Being tested
- questionnaire
- Keywords
- Practices, accompaniment, interdisciplinary, relatives, agonic phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
a questionnaire consisting of a list of support practices
| Study group | Role | What they receive |
|---|---|---|
| Physician | at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. Receives: Other: questionnaire | |
| Psychologists | at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. Receives: Other: questionnaire | |
| Caregivers | at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. Receives: Other: questionnaire | |
| Nurses | at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. Receives: Other: questionnaire | |
| Social and Educational Assistants | at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. Receives: Other: questionnaire | |
| Volunteers | at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. The representative participating in the study will preferably be the volunteer coordinator. Receives: Other: questionnaire | |
| Relatives | Relative of a patient who died in the palliative care unit at least 6 months ago Person to trust or to prevent if not designated Relative understanding and speaking sufficient French Relative not a health professional
Relative who visited the palliative care unit during the last 3 days of the patient's life and who met the care team:
* Traceability of the arrival of the loved one in the last 2/3 days of the patient's hospitalization
* Traceability of a meeting of the loved one with a member of the team over the last 3 days of his hospitalization or verification during telephone contact with the loved one after drawing lots Relative with an email address (to be verified during telephone contact with the loved one after drawing lots) Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree).
It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments.
Measured: Day 1
Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree).
It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments.
Measured: Month 2
Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree).
It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments.
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Dec 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Practice Nurse's ScopeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole ROUMIGUIERE, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818684
- Sponsor's protocol ID
- CHUBX 2019/60
- Acronym
- PROPAGE2
- Status last verified
- Jan 2024
- First submitted
- 25 Mar 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practices of Accompaniment of the Relatives of Patients in the Agonic Phase by an Interdisciplinary Team
- ClinicalTrials.gov ID
- NCT04818684
- Acronym / sponsor ID
- PROPAGE2 / CHUBX 2019/60
- Conditions
- Practice Nurse's Scope
- Keywords
- Practices, accompaniment, interdisciplinary, relatives, agonic phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 26 Mar 2021 (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 PROPAGE study program aims above all to improve the experience and satisfaction of family and friends regarding the support they receive during the dying person's agony phase.
Detailed description
The objective of PROPAGE 2 is to establish a consensus on the practices for accompanying relatives during the agonic phase in the context of hospitalization in the palliative care unit by an interdisciplinary team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Physician | – | Other: questionnaireat least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. |
| Psychologists | – | Other: questionnaireat least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. |
| Caregivers | – | Other: questionnaireat least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. |
| Nurses | – | Other: questionnaireat least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. |
| Social and Educational Assistants | – | Other: questionnaireat least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. |
| Volunteers | – | Other: questionnaireat least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. The representative participating in the study will preferably be the volunteer coordinator. |
| Relatives | – | Other: questionnaireRelative of a patient who died in the palliative care unit at least 6 months ago Person to trust or to prevent if not designated Relative understanding and speaking sufficient French Relative not a health professional Relative who visited the palliative care unit during the last 3 days of the patient's life and who met the care team: * Traceability of the arrival of the loved one in the last 2/3 days of the patient's hospitalization * Traceability of a meeting of the loved one with a member of the team over the last 3 days of his hospitalization or verification during telephone contact with the loved one after drawing lots Relative with an email address (to be verified during telephone contact with the loved one after drawing lots) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This includes people working in a palliative care unit as well as relatives who have known a patient in agony phase in a palliative care unit.
Key inclusion criteria (19 listed)
- PALLIATIVE CARE UNITS (USP) 35 palliative care unit will be drawn at random among the 164 French palliative care unit (www.sfap.org). In the event of refusal of participation, the drawing of lots will continue until 35 participating palliative care unit are obtained. The inclusion criteria for palliative care units were determined from the survey carried out in 2013 by the National End of Life Observatory on palliative care units in France. In order for there to be representativeness, the status of the palliative care unit will be taken into account from the national University Hospital (CHU) distribution, excluding CHU in the public sector, private non-profit sector, private for-profit sector. Thus, out of the 35 palliative care units: 7 will be within CHU, 16 will be outside CHU in the public sector, 7 will be in the private non-profit sector, and 5 in the private for-profit sector (criteria determined from the survey of the National End of Life Observatory in 2013) by ensuring that there are no more than 3 palliative care units in the same department (this in order to avoid that a geographical territory is over-represented, which would be liable to bias the results).
- In the event of refusal of a palliative care units or of inadequacy of the criteria, the drawing of lots will be continued until 35 participating USPs are obtained.
- Each team of these palliative care units must allow the participation of 7 experts: 1 for each group of experts, i.e. 5 socio-health professionals working in all the palliative care units (doctors, psychologists, nursing assistants, nurses, socio-educational assistant) as well as the coordinator of support volunteers and a relative by palliative care unit.
- THE EXPERTS
- 6 volunteer experts who will participate in the panel of voters: a doctor (group 1), an IDE ( group 2), an AS (group 3), a psychologist (group 4), an ASE (group 5), a volunteer support coordinator (group 6) . A relative (group 7) will be done.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| questionnairea questionnaire consisting of a list of support practices | Other | Caregivers, Nurses, Physician, Psychologists, Relatives, Social and Educational Assistants, Volunteers |
Primary outcome
Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree).
Time frame: Day 1
It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments.
Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree).
Time frame: Month 2
It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments.
Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree).
Time frame: Month 4
It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments.
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 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Carole ROUMIGUIERE study director
University Hospital, Bordeaux
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 Practice Nurse's Scope, run by University Hospital, Bordeaux 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 19 inclusion and 0 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 17 Jan 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?
Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree). (time frame: Day 1). The study lists 3 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 17 Jan 2024.