AnxietyFAMILLENCT01365377
Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU
A study testing booklet deliverance and use in the process of daily information in people with Anxiety and Depression, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses. Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anxiety, Depression, Post-traumatic Stress Disorders
- What is being tested?
- booklet deliverance and use in the process of daily information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Apr 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted in ICU whose previsible length of stay is over 3 days.
Who cannot join
- Admitted patient without organ failure
- Family member or patient who can't speak and/or read French
- Family who didn't show off within the first week of hospitalization
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
Jean-Jacques ROUBY, MD, PhD
About this study
Official title: Impact of the Deliverance and Use of a Written Detailed Information Brochure on Anxiety Felt by the Family Members of Patients Admitted in Intensive Care Unit
Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses.
Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R) is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey (SF-36) is an assessment of life quality.
Read more
In the following study, the investigators will evaluate the impact of a "brochure" as complement of oral information on Anxiety developed by relatives and family of ICU patients.
The medical and surgical ICU is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side.
During a year, in the first unit, the investigators will use the booklet as support and complement of oral information : "booklet arm". The information process will be as usual in the other unit : "control arm". During the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over).
For each included patient, one relative or family member is pointed to be the referring family member or "referent". This "referent" receives the HADS questionnaire at Day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. The IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36 questionnaire is given to the "referent" and the living patient at day 30. The day 30 questionnaires are send by mail at the "referent" address.
- Conditions
- Anxiety, Depression, Post-traumatic Stress Disorders
- Being tested
- booklet deliverance and use in the process of daily information
- Keywords
- Anxiety, Depression, Post-traumatic stress disorders, Quality of life, Family, ICU
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
booklet deliverance and use in the process of daily informationOther
Also called Brochure
The brochure shows with text and pictures the day-living of the ICU ; Medical and para-medical staff and organization, the devices, complications and treatment
| Study group | Role | What they receive |
|---|---|---|
| Booklet | Experimental | Referent member of the family is designated to receive a written detailed information on Critical care. Receives: Other: booklet deliverance and use in the process of daily information |
| No booklet | No intervention | daily information to the family is given as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU.
We hope to see the anxiety score decreasing between day of admission and day of discharge in the patient's relative who received the brocure.
Measured: One year per arm
Secondary outcomes (3)
Decreased of Depression Scoring on the HADS
We hope to see a decreasing of the Depression Score, which is part of the Hospital Anxiety and Depression Scale, in the group of patient's relatives receiving the booklet.
Measured: two years
Diagnostic and following of Post-traumatic stress disorder
We hope to see a decreasing of the score in the Impact Event Score (Revisited)in the group of patient's relatives receiving the booklet, showing a less risk of PTSD.
Measured: Two years
Assessment of quality of life in patients and relatives
A month after ICU discharge, we use the Short-Form 36 to assess quality of life of the surviving patients and their relative.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2013 (estimated)
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 AnxietyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365377
- Sponsor's protocol ID
- FAMILLE-JJR-2
- Acronym
- FAMILLE
- Status last verified
- Apr 2011
- First submitted
- 31 May 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
PubMed 15665319Jackson JC, Hart RP, Gordon SM, Shintani A, Truman B, May L, Ely EW. Six-month neuropsychological outcome of medical intensive care unit patients. Crit Care Med. 2003 Apr;31(4):1226-34. doi: 10.1097/01.CCM.0000059996.30263.94.
PubMed 12682497
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Deliverance and Use of a Written Detailed Information Brochure on Anxiety Felt by the Family Members of Patients Admitted in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01365377
- Acronym / sponsor ID
- FAMILLE / FAMILLE-JJR-2
- Conditions
- Anxiety, Depression, Post-traumatic Stress Disorders
- Keywords
- Anxiety, Depression, Post-traumatic stress disorders, Quality of life, Family, ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 3 Jun 2011 (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.
Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses.
Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R) is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey (SF-36) is an assessment of life quality.
In the following study, the investigators will evaluate the impact of a "brochure" as complement of oral information on Anxiety developed by relatives and family of ICU patients.
The medical and surgical ICU is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side.
During a year, in the first unit, the investigators will use the booklet as support and complement of oral information : "booklet arm". The information process will be as usual in the other unit : "control arm". During the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over).
For each included patient, one relative or family member is pointed to be the referring family member or "referent". This "referent" receives the HADS questionnaire at Day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. The IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36 questionnaire is given to the "referent" and the living patient at day 30. The day 30 questionnaires are send by mail at the "referent" address.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Booklet | Experimental | Other: booklet deliverance and use in the process of daily informationReferent member of the family is designated to receive a written detailed information on Critical care. |
| No booklet | No intervention | –daily information to the family is given as usual. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted in ICU whose previsible length of stay is over 3 days.
Key exclusion criteria (3 listed)
- Admitted patient without organ failure
- Family member or patient who can't speak and/or read French
- Family who didn't show off within the first week of hospitalization
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 |
|---|---|---|
| booklet deliverance and use in the process of daily informationAlso: BrochureThe brochure shows with text and pictures the day-living of the ICU ; Medical and para-medical staff and organization, the devices, complications and treatment | Other | Booklet |
Primary outcome
Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU.
Time frame: One year per arm
We hope to see the anxiety score decreasing between day of admission and day of discharge in the patient's relative who received the brocure.
3 secondary outcomes
Decreased of Depression Scoring on the HADS
Time frame: two years
Diagnostic and following of Post-traumatic stress disorder
Time frame: Two years
Assessment of quality of life in patients and relatives
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
- Background: PubMed 15665319Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
- Background: PubMed 12682497Jackson JC, Hart RP, Gordon SM, Shintani A, Truman B, May L, Ely EW. Six-month neuropsychological outcome of medical intensive care unit patients. Crit Care Med. 2003 Apr;31(4):1226-34. doi: 10.1097/01.CCM.0000059996.30263.94.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing booklet deliverance and use in the process of daily information in people with Anxiety and Depression, run by Groupe Hospitalier Pitie-Salpetriere 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jun 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Jacques ROUBY, MD, PhD (033-142177305, chunghi.do@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU. (time frame: One year per arm). 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 NCT01365377, 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 3 Jun 2011.