DeathFamirea 22NCT02325297
"Impacts of the Letter of Condolence to the Bereaved Families Experience After a Death in ICU " - Study Famirea 22
A study testing Letter of condolence in people with Death and Mourning, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
After the death of a patient in the hyper-technical context of intensive care, his relatives are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic stress and complicated grief. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Letter of condolence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- death of a relative patient in intensive care whose relatives were interviewed at least once by resuscitation team
- death of an adult relative patient
- ICU stay of the relative patient more than 2 days
Who cannot join
- death of a pregnant woman
- opposition to the use of its data by the patient
- relative does not speak French
- refusal of the relative
Trial locations and contacts
1 site in 1 country.
About this study
After the death of a patient in the hyper-technical context of intensive care, his relatives are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic stress and complicated grief. The first results of a qualitative study Famiréa current (CAESAR) support the idea that the bereaved relatives suffer from persistent misunderstandings and a feeling of abandonment of the resuscitation team. Many families suggest the need for contact with the team after the patient's death. The letter of condolence received by some families allowed them to feel recognized in their pain resuscitation teams. This has led us to ask the question of post-death monitoring and interest to send to bereaved relatives a letter of condolence, as recommended by the American consensus conference in 2004 on good palliative care. This strategy would allow the recognition of both close to the pain but also the strong bond that united the resuscitation team. The hypothesis of the study is that the post-death followed in the form of a letter of condolence sent by the intensive care physician who was in charge of the patient, could reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and reduce the rate of complicated grief.
Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who did not receive a letter of condolence and a group that received a letter of condolence 15 days after the death.
- Being tested
- Letter of condolence
- Keywords
- Intensive care unit
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter of condolenceOther
| Study group | Role | What they receive |
|---|---|---|
| Letter of condolence | Experimental | Letter of condolence 15 days after the death of the relative. Receives: Other: Letter of condolence |
| No letter of condolence | No intervention | No letter of condolence |
What is being measured
The primary outcome is the main question the study is designed to answer.
HADS (Hospital Anxiety and Depression Scale)
Measured: 1 month
Secondary outcomes (4)
Caesar scale
a questionnaire describing ICU end-of-life practices and satisfaction with the patient's care, communication, and symptom management during the dying process.
Measured: 1 month
IES-R (Impact of Event Scale, Revised)
Measured: 6 months
ICG (Inventory of Complicated grief)
Measured: 6 months
HADS (Hospital Anxiety and Depression Scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325297
- Sponsor's protocol ID
- Famirea22
- Acronym
- Famirea 22
- Status last verified
- Jun 2016
- First submitted
- 19 Dec 2014
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kentish-Barnes N, Chevret S, Champigneulle B, Thirion M, Souppart V, Gilbert M, Lesieur O, Renault A, Garrouste-Orgeas M, Argaud L, Venot M, Demoule A, Guisset O, Vinatier I, Troche G, Massot J, Jaber S, Bornstain C, Gaday V, Robert R, Rigaud JP, Cinotti R, Adda M, Thomas F, Calvet L, Galon M, Cohen-Solal Z, Cariou A, Azoulay E; Famirea Study Group. Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial. Intensive Care Med. 2017 Apr;43(4):473-484. doi: 10.1007/s00134-016-4669-9. Epub 2017 Feb 14.
PubMed 28197680Kentish-Barnes N, Chevret S, Azoulay E. Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial. Trials. 2016 Feb 20;17(1):102. doi: 10.1186/s13063-016-1212-9.
PubMed 26897630
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impacts of the Letter of Condolence to the Bereaved Families Experience After a Death in ICU " - Study Famirea 22
- ClinicalTrials.gov ID
- NCT02325297
- Acronym / sponsor ID
- Famirea 22 / Famirea22
- Keywords
- Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Dec 2014 (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.
After the death of a patient in the hyper-technical context of intensive care, his relatives are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic stress and complicated grief. The first results of a qualitative study Famiréa current (CAESAR) support the idea that the bereaved relatives suffer from persistent misunderstandings and a feeling of abandonment of the resuscitation team. Many families suggest the need for contact with the team after the patient's death. The letter of condolence received by some families allowed them to feel recognized in their pain resuscitation teams. This has led us to ask the question of post-death monitoring and interest to send to bereaved relatives a letter of condolence, as recommended by the American consensus conference in 2004 on good palliative care. This strategy would allow the recognition of both close to the pain but also the strong bond that united the resuscitation team. The hypothesis of the study is that the post-death followed in the form of a letter of condolence sent by the intensive care physician who was in charge of the patient, could reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and reduce the rate of complicated grief.
Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who did not receive a letter of condolence and a group that received a letter of condolence 15 days after the death.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letter of condolence | Experimental | Other: Letter of condolenceLetter of condolence 15 days after the death of the relative. |
| No letter of condolence | No intervention | –No letter of condolence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- death of a relative patient in intensive care whose relatives were interviewed at least once by resuscitation team
- death of an adult relative patient
- ICU stay of the relative patient more than 2 days
Key exclusion criteria (4 listed)
- death of a pregnant woman
- opposition to the use of its data by the patient
- relative does not speak French
- refusal of the relative
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 |
|---|---|---|
| Letter of condolence | Other | Letter of condolence |
Primary outcome
HADS (Hospital Anxiety and Depression Scale)
Time frame: 1 month
4 secondary outcomes
Caesar scale
Time frame: 1 month
IES-R (Impact of Event Scale, Revised)
Time frame: 6 months
ICG (Inventory of Complicated grief)
Time frame: 6 months
HADS (Hospital Anxiety and Depression Scale)
Time frame: 6 months
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 24 Jun 2016.
- Derived from this study: PubMed 28197680Kentish-Barnes N, Chevret S, Champigneulle B, Thirion M, Souppart V, Gilbert M, Lesieur O, Renault A, Garrouste-Orgeas M, Argaud L, Venot M, Demoule A, Guisset O, Vinatier I, Troche G, Massot J, Jaber S, Bornstain C, Gaday V, Robert R, Rigaud JP, Cinotti R, Adda M, Thomas F, Calvet L, Galon M, Cohen-Solal Z, Cariou A, Azoulay E; Famirea Study Group. Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial. Intensive Care Med. 2017 Apr;43(4):473-484. doi: 10.1007/s00134-016-4669-9. Epub 2017 Feb 14.
- Derived from this study: PubMed 26897630Kentish-Barnes N, Chevret S, Azoulay E. Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial. Trials. 2016 Feb 20;17(1):102. doi: 10.1186/s13063-016-1212-9.
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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 Letter of condolence in people with Death and Mourning, run by Assistance Publique - Hôpitaux de Paris 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 3 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 24 Jun 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?
HADS (Hospital Anxiety and Depression Scale) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325297, which also lists 2 linked publications.
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 24 Jun 2016.