Critical CarePARTICIPATENCT03090867
Participation of Relative or Surrogate in the Patient's Care in Reanimation
A study testing Relatives or surrogates are encouraged to perform care and Conventional ,care in people with Critical Care and Anxiety Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
ICUs have always perceived by the public has a very technical unit with a restricted and/or forbidden access. Physical alteration of the patient, seeing the patient sedated, the large numbers of devices, the alarms and an uncertain prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Anxiety Depression
- What is being tested?
- Relatives or surrogates are encouraged to perform care and Conventional ,care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2017to Feb 2020
- 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
- An adult related to the ICU patients, giving his written consent to participate to the study
- Being present at the patient's bedside at least twice a week
- Speaking and writing comprehension of the french language
- Adult ICU patient, admitted in the ICU for less than 72 hours, whatever its pathology
- Predictable ICU stay over a week
Who cannot join
- Refusal of the relative or surrogate
- Refusal of the patient
- The relative or surrogate can't be present at the patient's bedside at least twice a week
- Relative or surrogate already participating in the care of the patient for a chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
ICUs have always perceived by the public has a very technical unit with a restricted and/or forbidden access. Physical alteration of the patient, seeing the patient sedated, the large numbers of devices, the alarms and an uncertain prognosis. All this factors can be perceived by people close to the patient as a source of stress. In the literature, numerous studies have shown that families develop anxiety and depression symptoms while their loved one is hospitalized in the ICU. French intensive care societies thought of ways to prevent or diminish these symptoms. The 6th consensus conference on " Live better in the ICU " recommends: effective and adapted information, large visiting hours to reach an unrestricted access and family participation in care.
The unit has taken this path to improve patient and family centered care by: creating a welcome leaflet, a room dedicated to meetings with families and an ICU open 24/7bto families, with the possibility for children to visit their parents. Hence, spontaneously, relatives have expressed the wish to participate to certain care and when participating, expressed their satisfaction. This observation and testimonies from family members and patients led us to think about the impact of participation of care. Two major French studies have shown contradictory outcomes: 16% of families would have been willing to participate in the first study against 97% in the second one. These studies were survey done after the ICU discharge.
No study today has assessed the actual impact of family participation in care. The aim of this clinical trial is to diminish anxiety and depression symptoms. By participating in care, relatives can develop or strengthen a relationship of trust with caregivers. It could contribute also to a better understanding of the plan of care and an easier context to announce negative outcomes.
Read the detailed description
Randomisation visit - D1:
After checking the eligibilities criteria, a member of the staff will explain to the patient and his relative or surrogate the purpose and the planning of the study. The inform consent will be signed by the physician of the study. Two informs consents will be signed : one by the patient and the other one by the relative or surrogate. The randomisation will be done after collecting these consents.
After the draw, the subjects will be randomized either in the control group "Conventional support" or the experimental group "Intervention".
Questionnaires to be completed by the :
- relatives or surrogates: Hospital Anxiety and Depression scale (HAD scale), Multidimensional Fatigue Inventory (MFI20), Zarit Burden Interview (ZARIT sale) , Beck Depression Inventory (Beck), State-Trait Anxiety Scale (STAI) and "preliminary"
- patient if possible: HAD scale
Admission + 10 days visit:
Questionnaires to be completed by the relatives or surrogates: HAD scale, MIF20, ZARIT, Beck, STAI and "discharge"
ICU discharge visit :
Questionnaires to be completed by the :
- relatives or surrogates: HAD scale, MIF20, ZARIT, Beck, STAI and "discharge"
- patient if possible: HAD scale
Medical staff:
In order to evaluate the feeling of the ICU staff, a satisfaction questionnaire will be propose at the beginning and at the end of the study.
- Conditions
- Critical Care, Anxiety Depression
- Being tested
- Relatives or surrogates are encouraged to perform care, Conventional ,care
- Keywords
- Clinical Practice Guideline, Critical care, Family-centered care, Professional-family relations, Family nursing, Anxiety, Depression, Participation in care
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relatives or surrogates are encouraged to perform careOther
The relative or surrogate will perform at least two cares a week among feeding, mouth care, hair wash, shaving, eye care, hand, foot and face massage.
All care are planned and perform under the supervision or/and in collaboration with a caregiver.
The relative or surrogate will give his opinion by completing the study questionnaires.
Conventional ,careOther
The relative or surrogate will not be encouraged to perform care. The management of the relative or surrogate wi ll not changed from the regular standard of the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | Active comparator | The relative or surrogate will not be encouraged to perform care. The management of the relative or surrogate wi ll not changed from the regular standard of the ICU. Receives: Other: Conventional ,care |
| The relative/surrogate will be encouraged to perform care | Experimental | The relative or surrogate will perform at least two cares a week . A manual will be given to the relative or surrogate, explaining the different care he can choose to perform on the patient.
The care proposed are: feeding, mouth care, hair wash, shaving, eye care, hand, foot and face massage.
All care are planned and perform under the supervision or/and in collaboration with a caregiver.
Each care is written down on a collecting sheet. Receives: Other: Relatives or surrogates are encouraged to perform care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HAD scale at ICU's discharge
HAD Scale : The primary outcome measure is the relative or surrogate HAD (Hospital Anxiety and Depression Scale) score evolution.
The expected result is a reduction by two points of the total HAD score through active participation in care.
Measured: From baseline and at the patient's discharge from the ICU assessed up to 3 months
Secondary outcomes (6)
Evolution of the relative or surrogate anxiety/depression
The relative or surrogate will complete the HAD scale and other anxiety/depression questionnaires.
Measured: at baseline and after 10 days of ICU hospitalization.
Evolution of the relative or surrogate anxiety/depression
The relative or surrogate will complete the HAD scale questionnaires and anxiety/depression questionnaires.
Measured: at baseline and at ICU's discharge assessed up to 3 months
Evaluation of the satisfaction's relatives or surrogates regarding their participation in the ICU patient care by a questionnaire
Concern different aspects of the patient's management: listening skills and support from the ICU team, medical information about the patient, benefits and difficulties encountered while participating in care
Measured: At the patient's ICU discharge assessed up to 3 months
Evaluation of the satisfaction of the ICU staff by a questionnaire
Evaluate the feeling of the ICU staff regarding participation in care of surrogates and assess its evolution at the end of the study.
The ICU staff can describe which benefits and difficuties they encountered while caring for the patient with the relative or surrogate.
At initiation visit and at closing of the center
Measured: Through study completion an average of 12 months
Quantify which care have been realized by the relatives or surrogates
Each time a relative or surrogate is caring for the patient, the ICU staff will write it on a specific sheet.
At the end of the study, all this data will be gathered to see which care have been done more often
Measured: Through study completion an average of 12 months
HAD scale of the patient
The patient completes the HAD scale if his mental state allows it
Measured: At the ICU discharge assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start16 Nov 2017
- Primary completion15 Nov 2019
- Study completionFeb 2020 (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 Critical CareStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ICAN Nutrition Education and Research
- Responsible party
- Sponsor
- Investigators
- Alain COMBES, M.D, Ph.D, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090867
- Sponsor's protocol ID
- P150301
- Acronym
- PARTICIPATE
- Status last verified
- Jan 2020
- First submitted
- 6 Feb 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azoulay E, Pochard F, Chevret S, Arich C, Brivet F, Brun F, Charles PE, Desmettre T, Dubois D, Galliot R, Garrouste-Orgeas M, Goldgran-Toledano D, Herbecq P, Joly LM, Jourdain M, Kaidomar M, Lepape A, Letellier N, Marie O, Page B, Parrot A, Rodie-Talbere PA, Sermet A, Tenaillon A, Thuong M, Tulasne P, Le Gall JR, Schlemmer B; French Famirea Group. Family participation in care to the critically ill: opinions of families and staff. Intensive Care Med. 2003 Sep;29(9):1498-504. doi: 10.1007/s00134-003-1904-y. Epub 2003 Jul 10.
PubMed 12856124Garrouste-Orgeas M, Willems V, Timsit JF, Diaw F, Brochon S, Vesin A, Philippart F, Tabah A, Coquet I, Bruel C, Moulard ML, Carlet J, Misset B. Opinions of families, staff, and patients about family participation in care in intensive care units. J Crit Care. 2010 Dec;25(4):634-40. doi: 10.1016/j.jcrc.2010.03.001.
PubMed 20435430
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation of Relative or Surrogate in the Patient's Care in Reanimation
- ClinicalTrials.gov ID
- NCT03090867
- Acronym / sponsor ID
- PARTICIPATE / P150301
- Conditions
- Critical Care, Anxiety Depression
- Keywords
- Clinical Practice Guideline, Critical care, Family-centered care, Professional-family relations, Family nursing, Anxiety, Depression, Participation in care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ICAN Nutrition Education and Research
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 27 Mar 2017 (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.
ICUs have always perceived by the public has a very technical unit with a restricted and/or forbidden access. Physical alteration of the patient, seeing the patient sedated, the large numbers of devices, the alarms and an uncertain prognosis. All this factors can be perceived by people close to the patient as a source of stress. In the literature, numerous studies have shown that families develop anxiety and depression symptoms while their loved one is hospitalized in the ICU. French intensive care societies thought of ways to prevent or diminish these symptoms. The 6th consensus conference on " Live better in the ICU " recommends: effective and adapted information, large visiting hours to reach an unrestricted access and family participation in care.
The unit has taken this path to improve patient and family centered care by: creating a welcome leaflet, a room dedicated to meetings with families and an ICU open 24/7bto families, with the possibility for children to visit their parents. Hence, spontaneously, relatives have expressed the wish to participate to certain care and when participating, expressed their satisfaction. This observation and testimonies from family members and patients led us to think about the impact of participation of care. Two major French studies have shown contradictory outcomes: 16% of families would have been willing to participate in the first study against 97% in the second one. These studies were survey done after the ICU discharge.
No study today has assessed the actual impact of family participation in care. The aim of this clinical trial is to diminish anxiety and depression symptoms. By participating in care, relatives can develop or strengthen a relationship of trust with caregivers. It could contribute also to a better understanding of the plan of care and an easier context to announce negative outcomes.
Detailed description
Randomisation visit - D1:
After checking the eligibilities criteria, a member of the staff will explain to the patient and his relative or surrogate the purpose and the planning of the study. The inform consent will be signed by the physician of the study. Two informs consents will be signed : one by the patient and the other one by the relative or surrogate. The randomisation will be done after collecting these consents.
After the draw, the subjects will be randomized either in the control group "Conventional support" or the experimental group "Intervention".
Questionnaires to be completed by the :
- relatives or surrogates: Hospital Anxiety and Depression scale (HAD scale), Multidimensional Fatigue Inventory (MFI20), Zarit Burden Interview (ZARIT sale) , Beck Depression Inventory (Beck), State-Trait Anxiety Scale (STAI) and "preliminary"
- patient if possible: HAD scale
Admission + 10 days visit:
Questionnaires to be completed by the relatives or surrogates: HAD scale, MIF20, ZARIT, Beck, STAI and "discharge"
ICU discharge visit :
Questionnaires to be completed by the :
- relatives or surrogates: HAD scale, MIF20, ZARIT, Beck, STAI and "discharge"
- patient if possible: HAD scale
Medical staff:
In order to evaluate the feeling of the ICU staff, a satisfaction questionnaire will be propose at the beginning and at the end of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | Active comparator | Other: Conventional ,careThe relative or surrogate will not be encouraged to perform care. The management of the relative or surrogate wi ll not changed from the regular standard of the ICU. |
| The relative/surrogate will be encouraged to perform care | Experimental | Other: Relatives or surrogates are encouraged to perform careThe relative or surrogate will perform at least two cares a week . A manual will be given to the relative or surrogate, explaining the different care he can choose to perform on the patient. The care proposed are: feeding, mouth care, hair wash, shaving, eye care, hand, foot and face massage. All care are planned and perform under the supervision or/and in collaboration with a caregiver. Each care is written down on a collecting sheet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An adult related to the ICU patients, giving his written consent to participate to the study
- Being present at the patient's bedside at least twice a week
- Speaking and writing comprehension of the french language
- Adult ICU patient, admitted in the ICU for less than 72 hours, whatever its pathology
- Predictable ICU stay over a week
Key exclusion criteria (4 listed)
- Refusal of the relative or surrogate
- Refusal of the patient
- The relative or surrogate can't be present at the patient's bedside at least twice a week
- Relative or surrogate already participating in the care of the patient for a chronic disease
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 |
|---|---|---|
| Relatives or surrogates are encouraged to perform careThe relative or surrogate will perform at least two cares a week among feeding, mouth care, hair wash, shaving, eye care, hand, foot and face massage. All care are planned and perform under the supervision or/and in collaboration with a caregiver. The relative or surrogate will give his opinion by completing the study questionnaires. | Other | The relative/surrogate will be encouraged to perform care |
| Conventional ,careThe relative or surrogate will not be encouraged to perform care. The management of the relative or surrogate wi ll not changed from the regular standard of the ICU. | Other | Conventional arm |
Primary outcome
Change from baseline HAD scale at ICU's discharge
Time frame: From baseline and at the patient's discharge from the ICU assessed up to 3 months
HAD Scale : The primary outcome measure is the relative or surrogate HAD (Hospital Anxiety and Depression Scale) score evolution. The expected result is a reduction by two points of the total HAD score through active participation in care.
6 secondary outcomes
Evolution of the relative or surrogate anxiety/depression
Time frame: at baseline and after 10 days of ICU hospitalization.
Evolution of the relative or surrogate anxiety/depression
Time frame: at baseline and at ICU's discharge assessed up to 3 months
Evaluation of the satisfaction's relatives or surrogates regarding their participation in the ICU patient care by a questionnaire
Time frame: At the patient's ICU discharge assessed up to 3 months
Evaluation of the satisfaction of the ICU staff by a questionnaire
Time frame: Through study completion an average of 12 months
Quantify which care have been realized by the relatives or surrogates
Time frame: Through study completion an average of 12 months
HAD scale of the patient
Time frame: At the ICU discharge assessed up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 12856124Azoulay E, Pochard F, Chevret S, Arich C, Brivet F, Brun F, Charles PE, Desmettre T, Dubois D, Galliot R, Garrouste-Orgeas M, Goldgran-Toledano D, Herbecq P, Joly LM, Jourdain M, Kaidomar M, Lepape A, Letellier N, Marie O, Page B, Parrot A, Rodie-Talbere PA, Sermet A, Tenaillon A, Thuong M, Tulasne P, Le Gall JR, Schlemmer B; French Famirea Group. Family participation in care to the critically ill: opinions of families and staff. Intensive Care Med. 2003 Sep;29(9):1498-504. doi: 10.1007/s00134-003-1904-y. Epub 2003 Jul 10.
- Background: PubMed 20435430Garrouste-Orgeas M, Willems V, Timsit JF, Diaw F, Brochon S, Vesin A, Philippart F, Tabah A, Coquet I, Bruel C, Moulard ML, Carlet J, Misset B. Opinions of families, staff, and patients about family participation in care in intensive care units. J Crit Care. 2010 Dec;25(4):634-40. doi: 10.1016/j.jcrc.2010.03.001.
- 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.
Alain COMBES, M.D, Ph.D principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relatives or surrogates are encouraged to perform care and Conventional ,care in people with Critical Care and Anxiety Depression, 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 5 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. 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?
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?
Change from baseline HAD scale at ICU's discharge (time frame: From baseline and at the patient's discharge from the ICU assessed up to 3 months). 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 NCT03090867, 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 28 Jan 2020.