Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients in a Vegetative State (REVE)
Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients With an Unresponsive Wakefulness Syndrome
Progress in resuscitation has increased the chances of survival after anoxic or traumatic brain injury. More and more patients with severe cerebral damages are resuscitated but upon awakening from coma, some patients remain in a state which cannot be qualified as conscious and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative state). This condition can be transitory and evolve towards recovery, or remain chronic and lasting for years.
To improve the diagnosis of patients with disorders of consciousness, recent advances in brain imaging have led to the development of new methods of detecting awareness. In the absence of overt behavioral responses from these patients, imaging-based diagnostic methods have been first used to assess whether some cerebral areas were preserved in UWS patients and showed an activation of the primary sensory cortices in some UWS patients, whether it occurs at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are raised for clinicians before responding to such requests:
- Is it technically possible to generalize neuroimaging protocols to all healthcare institutions?
- Is it ethically acceptable to propose neuroimaging protocols without an accurate estimation of their psychological impact on families and caregivers?
The present study aims to understand and anticipate the technical and ethical issues related to an evaluation of consciousness with functional neuroimaging. How the evaluation of awareness in a patient affects the caregivers and family members will be investigated. By using qualitative research hopes and expectations will be clarified through the experiences of families, clinicians and nurses faced to this situation.
Will be included in this research professional caregivers and persons closely related to UWS patients:
- Family members or close circle visiting the patients on a regular basis
- Referring clinicians
- Nurses in charge of the patients' care
This prospective study uses qualitative, interview-based, research. Two key-moments are explored in succession to examine the impact of a neuroimaging evaluation of consciousness in institutionalized UWS patients:
- interviews of professional caregivers and families about their hopes concerning the evaluation of consciousness of UWS patients,
- interviews of professional caregivers and families about the impact of evaluating consciousness on their beliefs
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Besançon, France, 25000
- Etablissement de rééducation fonctionnelle Les Salins de Bregille
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Héricourt, France, 70400
- Etablissement de rééducation fonctionnelle Bretégnier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult family members, clinicians, nurses (aged >18 years) closely related to UWS patients
- patients diagnosed as being in an UWS
Exclusion Criteria:
- patients in a minimally conscious state, in a locked-in-syndrome of akinetic mutism
- refusal of family members, clinicians or nurses to participate to the study
- family members considered by clinicians not to be capable of passing the interviews
- subjects aged < 18 years
- non french speaking subjects
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: qualitative and neuroimaging research
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions of physicians and family members toward neuroimaging exams
Time Frame: day one
|
semi-structured interviews before the neuroimaging exams
|
day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions of physicians and family members of the neuroimaging exams results
Time Frame: day seven
|
semi-structured interviews after the neuroimaging exams
|
day seven
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Régis AUBRY, Pr, Centre Hospitalier Universitaire de Besancon
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REVE
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