The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family MembersAFPNCT04423809
Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study
An observational study of The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members
- What is being tested?
- clinical assessment
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2015to 27 Mar 2020
- Phase
- Observational
- 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
Study population: caregiver of patient hospitalised in psychiatry
Who may be able to join
- Family members or relatives
- Over 18 years
- Having a relative
- First hospitalized in psychiatry or hospitalized in psychiatry within 5 years
- Over 18 years of age
- Psychotic episode
Show all 10Show fewer
- Having been informed of their participation in this study
- In regular contact with the patient prior to hospitalization, at least 4 hours per week.
- French language
- Signed written informed consent.
Who cannot join
- -Psychiatric pathology of another family member than the hospitalized.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de recherche clinique
Neuilly-sur-Marne, Île-de-France Region, 93330
About this study
Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry.
Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.
- Being tested
- clinical assessment
- Keywords
- Psychiatry Nurse Burden Caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assessmentOther
Also called Interview
assessment of caregivers suffering when a family member is hospitalized
| Study group | Role | What they receive |
|---|---|---|
| caregivers of adult patients hospitalized in psychiatry | a face-to-face interview with a nurse and self-assessment scales. Receives: Other: clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies-Depression scale
is a simple tool for assessing depressive symptomatology for the general population
Measured: at patient admission
Secondary outcomes (3)
Zarit burden inventory
to assess burden
Measured: at patient admission
Short form 36
To assess quality of life
Measured: at patient admission
Semi-directional interview
It consists of five items: subjective feeling, quality of life, social life, mood of the caregiver.
Measured: At patient admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Jun 2015
- Primary completion8 Jun 2018
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family MembersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Januel, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423809
- Sponsor's protocol ID
- 2014-A01499-38
- Acronym
- AFP
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study
- ClinicalTrials.gov ID
- NCT04423809
- Acronym / sponsor ID
- AFP / 2014-A01499-38
- Keywords
- Psychiatry Nurse Burden Caregiver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 9 Jun 2020 (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.
Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry.
Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caregivers of adult patients hospitalized in psychiatry | – | Other: clinical assessmenta face-to-face interview with a nurse and self-assessment scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- caregiver of patient hospitalised in psychiatry
Key inclusion criteria (10 listed)
- Family members or relatives
- Over 18 years
- Having a relative
- In regular contact with the patient prior to hospitalization, at least 4 hours per week.
- French language
Key exclusion criteria (1 listed)
- -Psychiatric pathology of another family member than the hospitalized.
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 |
|---|---|---|
| clinical assessmentAlso: Interviewassessment of caregivers suffering when a family member is hospitalized | Other | caregivers of adult patients hospitalized in psychiatry |
Primary outcome
Center for Epidemiologic Studies-Depression scale
Time frame: at patient admission
is a simple tool for assessing depressive symptomatology for the general population
3 secondary outcomes
Zarit burden inventory
Time frame: at patient admission
Short form 36
Time frame: at patient admission
Semi-directional interview
Time frame: At patient admission
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 9 Jun 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members, run by Centre hospitalier de Ville-Evrard, France 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 10 inclusion and 1 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 9 Jun 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?
Center for Epidemiologic Studies-Depression scale (time frame: at patient admission). 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 9 Jun 2020.