Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-06 @ 10:19 AM
Study NCT ID:
NCT03090867
Status:
UNKNOWN
Last Update Posted:
2020-01-28
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Participation of Relative or Surrogate in the Patient's Care in Reanimation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Participation of Relative or Surrogate in the Patient's Care in Reanimation
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARTICIPATE
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: