AnxietyVécu/Tiers/PsyNCT03510039
Early Intervention AND NURSING Support for an " Involuntary Commitment Procedure " for a Close Relative
A study testing Early device / Follow up in people with Anxiety, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In a context of first hospitalization under the constraint of a relative in psychiatric emergencies: effect of an early intervention and a 6-month nursing follow-up on the anxious experience of third party persons effect of nursing support on family dynamics, on the durability of outpatient care and adherence Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Early device / Follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2018to 13 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being the "Third Party" adult, during the first involuntary commitment procedure of a close relative, in an ASPDT(u) form.
- Being physically present during the admission, within 24 hours after the arrival of the patient.
- Accept to be recontacted by phone to J7, M2, M4 and M6
- Affiliated person or beneficiary of a social security scheme.
- Free and informed consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Who cannot join
- To be the guardian or any person in charge of legal representation with the patient.
- Pregnant or lactating woman (the duration of the study may affect the subject's compliance and availability).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Describing the Effect of an Early Nursing Intervention Device on the Anxious Experience of "Third-party" People Who Participate in the First Involuntary Commitment Hospitalization From a Relative
In a context of first hospitalization under the constraint of a relative in psychiatric emergencies:
- effect of an early intervention and a 6-month nursing follow-up on the anxious experience of third party persons
- effect of nursing support on family dynamics, on the durability of outpatient care and adherence
Read the detailed description
The patient that is meeting during time travel at Psychiatric Emergency come with their families wich live (or have been lived) the crisis at home, in the street, with their family doctor. With a psychic incoming sufferance, when the patient refuses his medicines, doctors ask to someone close to the patient to become his Third party, his first guarantor of the without consent care commitment. These without consent hospitalizations at Toulouse University Hospital, and all over France hospitals, rise continuously. Our daily nursing exercise is to support those helping people. The sentiment felt by our nursing team during the exchange, underlines ambivalence and several emotional problems and difficulties, which are even harder for a first time occurence.
Patient's close relatives that become a " resource " during non-consensual hospitalization could be affected indirectly by the burden of this referent role. Between culpability, isolation and exhaustion, the studies show that their ability to " resist " is a real help for patient progression. This statement is showed by nursing team (even belonging to others structures) listened during our exploratory investigation.In our professional practice, our specific emergency environment is firstly focused about patient in crisis situation and about his security. In this environment, there is no formerly dedicated time for relatives needing, once actors and public in this acute disease. Relatives hard experiences in a very central moment that we could consider as care beginnings, should impact therapy and patient health care plan. An early, well defined nursing act, built on close relatives needs and expectations could enhance this particular moment that should facilitate the following of the patient disease. A lot of data cited in literature specify the central role of relatives for a psychic patient, but there is no study about an early nursing intervention for Relatives during a psychiatric emergency.
- Conditions
- Anxiety
- Being tested
- Early device / Follow up, Usual care
- Keywords
- Involuntary commitment hospitalization, close relative
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early device / Follow upBehavioural
Early device:
Standardized Nursing Interview (30 minutes) with the Third Party Person Measure and follow the anxiety of the Third Party by rating the AMDP-AT scale, on D0 and D7
Telephone follow-up by nurses:
Interviews built and standardized, to M2, M4 and M6 Quantification of the AMDP-AT anxiety scale on each call
Usual careOther
Group "Before" : usual care by nurses
| Study group | Role | What they receive |
|---|---|---|
| "Before" Group | Active comparator | 35 Thirds benefiting from the usual care Receives: Other: Usual care |
| "After" Group | Experimental | Recruit 35 Thirds for the phase phase "After" : Early device / Follow up by nurses Receives: Behavioral: Early device / Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of early nursing intervention in the short term on the experience of the close relative
Effect of early nursing intervention in the short term on the experience of the close relative compared to current support Measured by the evolution between D0 and D7 (first follow-up call telephone) with the AMDP-AT anxiety scale The AMDP system is a clinical measure of psychopathology. The Association de Methodology and Documentation in Psychiatry has developed this system of standardized quantification of psychopathology This is a synthetic version of 17 anxiety items (with a score included between 0 and 68), which is therefore a shorter scale than the full AMDP scale The AMDP-AT is particularly adapted to our emergency situation to assess the experience of the close relative, because it takes into account the multiple dimensions at the moment of the immediate anxiety situation
Measured: 6 month
Secondary outcomes (2)
Number of visits to the attending physician, consultations at the Psychological health center
Number of visits to the attending physician, consultations at the Psychological health center, appeals psychiatric emergencies, psychiatric emergency room visits and hospital admissions possible, patients whose close relative has benefited from the "After" phase, compared to in current load, counted by calls for both groups to M2, M4 and M6. The calls will be non-interventional for the "Before" phase, and formalized interventional for the phase "After"
Measured: 6 months
Effect of nurse intervention over the medium term on the experience of the close relative
Effect of the intervention of the nurses in the medium term on the experience of the close relative, measured by the change between J0 and M6 by Telephone Tracking Calls with Anxiety Scale AMDP-AT
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 posted27 Apr 2018
- Study start15 Mar 2018
- Primary completion15 Mar 2020
- Study completion13 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- Mono-centric pilot comparative study like " Before /After ". It will be necessary to recruit at first 35 thirds benefiting from the in current load, "Before" phase, then to set up our intervention, and recruit another 35 different thirds for the "After".
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre CASTANET, nurse, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510039
- Sponsor's protocol ID
- RC31/17/0322
- Other IDs
- 2017-A03043-50
- Acronym
- Vécu/Tiers/Psy
- Status last verified
- Nov 2020
- First submitted
- 9 Mar 2018
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Describing the Effect of an Early Nursing Intervention Device on the Anxious Experience of "Third-party" People Who Participate in the First Involuntary Commitment Hospitalization From a Relative
- ClinicalTrials.gov ID
- NCT03510039
- Acronym / sponsor ID
- Vécu/Tiers/Psy / RC31/17/0322
- Conditions
- Anxiety
- Keywords
- Involuntary commitment hospitalization, close relative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 13 Sep 2020 (actual)
- First posted
- 27 Apr 2018 (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.
In a context of first hospitalization under the constraint of a relative in psychiatric emergencies:
- effect of an early intervention and a 6-month nursing follow-up on the anxious experience of third party persons
- effect of nursing support on family dynamics, on the durability of outpatient care and adherence
Detailed description
The patient that is meeting during time travel at Psychiatric Emergency come with their families wich live (or have been lived) the crisis at home, in the street, with their family doctor. With a psychic incoming sufferance, when the patient refuses his medicines, doctors ask to someone close to the patient to become his Third party, his first guarantor of the without consent care commitment. These without consent hospitalizations at Toulouse University Hospital, and all over France hospitals, rise continuously. Our daily nursing exercise is to support those helping people. The sentiment felt by our nursing team during the exchange, underlines ambivalence and several emotional problems and difficulties, which are even harder for a first time occurence.
Patient's close relatives that become a " resource " during non-consensual hospitalization could be affected indirectly by the burden of this referent role. Between culpability, isolation and exhaustion, the studies show that their ability to " resist " is a real help for patient progression. This statement is showed by nursing team (even belonging to others structures) listened during our exploratory investigation.In our professional practice, our specific emergency environment is firstly focused about patient in crisis situation and about his security. In this environment, there is no formerly dedicated time for relatives needing, once actors and public in this acute disease. Relatives hard experiences in a very central moment that we could consider as care beginnings, should impact therapy and patient health care plan. An early, well defined nursing act, built on close relatives needs and expectations could enhance this particular moment that should facilitate the following of the patient disease. A lot of data cited in literature specify the central role of relatives for a psychic patient, but there is no study about an early nursing intervention for Relatives during a psychiatric emergency.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mono-centric pilot comparative study like " Before /After ". It will be necessary to recruit at first 35 thirds benefiting from the in current load, "Before" phase, then to set up our intervention, and recruit another 35 different thirds for the "After".
| Arm | Type | Receives |
|---|---|---|
| "Before" Group | Active comparator | Other: Usual care35 Thirds benefiting from the usual care |
| "After" Group | Experimental | Behavioral: Early device / Follow upRecruit 35 Thirds for the phase phase "After" : Early device / Follow up by nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being the "Third Party" adult, during the first involuntary commitment procedure of a close relative, in an ASPDT(u) form.
- Being physically present during the admission, within 24 hours after the arrival of the patient.
- Accept to be recontacted by phone to J7, M2, M4 and M6
- Affiliated person or beneficiary of a social security scheme.
- Free and informed consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Key exclusion criteria (2 listed)
- To be the guardian or any person in charge of legal representation with the patient.
- Pregnant or lactating woman (the duration of the study may affect the subject's compliance and availability).
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 |
|---|---|---|
| Early device / Follow upEarly device: Standardized Nursing Interview (30 minutes) with the Third Party Person Measure and follow the anxiety of the Third Party by rating the AMDP-AT scale, on D0 and D7 Telephone follow-up by nurses: Interviews built and standardized, to M2, M4 and M6 Quantification of the AMDP-AT anxiety scale on each call | Behavioural | "After" Group |
| Usual careGroup "Before" : usual care by nurses | Other | "Before" Group |
Primary outcome
Effect of early nursing intervention in the short term on the experience of the close relative
Time frame: 6 month
Effect of early nursing intervention in the short term on the experience of the close relative compared to current support Measured by the evolution between D0 and D7 (first follow-up call telephone) with the AMDP-AT anxiety scale The AMDP system is a clinical measure of psychopathology. The Association de Methodology and Documentation in Psychiatry has developed this system of standardized quantification of psychopathology This is a synthetic version of 17 anxiety items (with a score included between 0 and 68), which is therefore a shorter scale than the full AMDP scale The AMDP-AT is particularly adapted to our emergency situation to assess the experience of the close relative, because it takes into account the multiple dimensions at the moment of the immediate anxiety situation
2 secondary outcomes
Number of visits to the attending physician, consultations at the Psychological health center
Time frame: 6 months
Effect of nurse intervention over the medium term on the experience of the close relative
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 10 Nov 2020.
- 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.
Alexandre CASTANET, nurse principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early device / Follow up in people with Anxiety, run by University Hospital, Toulouse 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 2 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 10 Nov 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?
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?
Effect of early nursing intervention in the short term on the experience of the close relative (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2020.