Suicide, AttemptedProFAESNCT03162744
Protective Factors Against Elderly Suicide
An observational study of Suicide, Attempted and Suicide Gesture, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial summary
Suicidal intentionality is generally stronger among the elderly, suicidal acts are more violent and are combined with a greater physical fragility. The suicide of an older adult is a situation that often leads to helplessness feelings. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Suicide, Attempted, Suicide Gesture
- What is being tested?
- Post-suicidal crisis interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2018to 27 May 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients will be screened in the psychiatric, geriatric and emergency departments of la Rochelle and Rochefort secondary hospitals
Who may be able to join
- Attempted suicide and / or suicidal ideas
- Informed and agreed to participate
Who cannot join
- Cognitive disorders
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methodical Search of Protective Factors During Interview of Suicidal Elderly Patients: Effect on the Proposed Care
Suicidal intentionality is generally stronger among the elderly, suicidal acts are more violent and are combined with a greater physical fragility. The suicide of an older adult is a situation that often leads to helplessness feelings.
Analysis of the literature reveals two types of major interventions in order to reduce suicide rate: reducing risk factors and increasing protective factors. Risk factors are well documented, particularly from studies using psychological autopsies. However, protective factors are much less studied for the elderly. Yet the identification of relevant and available protective mechanisms in a suicidal crisis is essential to effectively guide nurses and health professionals in therapeutic commitment and intervention.
Read the detailed description
France has a suicide rate (16.2 per 100 000 inhabitants) well above the European average rate (10.2 per 100 000 inhabitants). The Poitou-Charentes region is in a situation of excess mortality by suicide compared to France (+ 25%). While the ratio of suicide attempts per suicide is about 200/1 before 25 years, it is estimated to be 4/1 after 65 years, or even 1/1 in elderly men. In France, suicide attempts are not systematically recorded and the frequency of suicidal ideation is poorly understood. The consensus conference on suicidal crisis highlights a number of clinical points specific to the elderly population (suicidal ideas are not always clearly expressed or unidentified, there are various manifestations of the psychic crisis, greater vulnerability of this population), but the complexity of interactions between suicidal risk factors limits our predictive capabilities of suicidal intention in an elderly person. Analysis of the literature reveals two types of major interventions in order to reduce the suicide rate: those aimed at reducing risk factors and those aimed at increasing protective factors. The objective of our research is to determine the effect of protective factor methodical search on post-crisis patient care.
- Conditions
- Suicide, Attempted, Suicide Gesture
- Being tested
- Post-suicidal crisis interview
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-suicidal crisis interviewBehavioural
Protective factor exploration during post-suicidal crisis interview
| Study group | Role | What they receive |
|---|---|---|
| Suicide attempt or ideas | Elderly patients who attempted suicide or who emitted suicidal ideas Receives: Behavioral: Post-suicidal crisis interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of outpatients (with a low to moderate risk of suicidal recurrence)
Based on risk, emergency and hazard, patients are classified as being at low, moderate and high risk of suicidal recurrence. Patients with low to moderate risk of suicidal recurrence are either inpatient or outpatient.
Measured: 7 days
Secondary outcomes (12)
Number of patients considering themselves to be in good health
Score > 0 at Health Status questionnaire (SF36) item 1
Measured: 7 days
Number of patients considering that their physical or mental state did not alter their social life
Score > 50 at Health Status questionnaire (SF36) items 6 or 10
Measured: 7 days
Number of patients maintaining autonomy
Score = 0 at Instrumental Activities of Daily Living scale
Measured: 7 days
Number of patients with religious practice
Binary answer from patients (yes/no I have a religious practice)
Measured: 7 days
Number of patients with a sense of success and self-esteem
Binary answer from patients (yes/no I have a a sense of success and self-esteem)
Measured: 7 days
Number of patients considering their family environment to be satisfactory
Binary answer from patients (yes/no I am satisfied with my family environment)
Measured: 7 days
Number of patients with at least one environmental protection factor
Friendly network, associative investment, volunteering, specialized care, recreation, positive image from the entourage, presence of a third party, housekeeper, postman, pet, shopping facilities, doctor, pharmacy ...
Measured: 7 days
Number of patients with social protection factors
Easy access to Health facilities, sufficient financial income
Measured: 7 days
Number of patients able to adapt to difficult situations
score ≤ 12 at Neo Personality Inventory vulnerability item
Measured: 7 days
Number of patients with extraversion capabilities
score ≥ 20 at Neo Personality Inventory extraversion item
Measured: 7 days
Number of patients with openness to others
score ≥ 20 at Neo Personality Inventory Openness to feelings item
Measured: 7 days
Number of patients considering that their health has improved
Patients will be asked if they feel that their health has improved, has not changed or has worsened
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start16 Feb 2018
- Primary completion16 Feb 2019
- Study completion27 May 2019
Why it stopped: Inclusion difficulties, Investigator lack of time for the study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine REISS, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162744
- Sponsor's protocol ID
- 2015/P08/079
- Acronym
- ProFAES
- Status last verified
- Jul 2019
- First submitted
- 19 May 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Richard-Devantoy S, Jollant F. [Suicide in the elderly: age-related specificities?]. Sante Ment Que. 2012 Autumn;37(2):151-73. doi: 10.7202/1014949ar. French.
PubMed 23666286Conwell Y, Thompson C. Suicidal behavior in elders. Psychiatr Clin North Am. 2008 Jun;31(2):333-56. doi: 10.1016/j.psc.2008.01.004.
PubMed 18439452Casadebaig F, Ruffin D, Philippe A. [Suicide in the elderly at home and in retirement homes in France]. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):55-64. French.
PubMed 12684581
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodical Search of Protective Factors During Interview of Suicidal Elderly Patients: Effect on the Proposed Care
- ClinicalTrials.gov ID
- NCT03162744
- Acronym / sponsor ID
- ProFAES / 2015/P08/079
- Conditions
- Suicide, Attempted, Suicide Gesture
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusion difficulties, Investigator lack of time for the study completion
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 22 May 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.
Suicidal intentionality is generally stronger among the elderly, suicidal acts are more violent and are combined with a greater physical fragility. The suicide of an older adult is a situation that often leads to helplessness feelings.
Analysis of the literature reveals two types of major interventions in order to reduce suicide rate: reducing risk factors and increasing protective factors. Risk factors are well documented, particularly from studies using psychological autopsies. However, protective factors are much less studied for the elderly. Yet the identification of relevant and available protective mechanisms in a suicidal crisis is essential to effectively guide nurses and health professionals in therapeutic commitment and intervention.
Detailed description
France has a suicide rate (16.2 per 100 000 inhabitants) well above the European average rate (10.2 per 100 000 inhabitants). The Poitou-Charentes region is in a situation of excess mortality by suicide compared to France (+ 25%). While the ratio of suicide attempts per suicide is about 200/1 before 25 years, it is estimated to be 4/1 after 65 years, or even 1/1 in elderly men. In France, suicide attempts are not systematically recorded and the frequency of suicidal ideation is poorly understood. The consensus conference on suicidal crisis highlights a number of clinical points specific to the elderly population (suicidal ideas are not always clearly expressed or unidentified, there are various manifestations of the psychic crisis, greater vulnerability of this population), but the complexity of interactions between suicidal risk factors limits our predictive capabilities of suicidal intention in an elderly person. Analysis of the literature reveals two types of major interventions in order to reduce the suicide rate: those aimed at reducing risk factors and those aimed at increasing protective factors. The objective of our research is to determine the effect of protective factor methodical search on post-crisis patient care.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suicide attempt or ideas | – | Behavioral: Post-suicidal crisis interviewElderly patients who attempted suicide or who emitted suicidal ideas |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients will be screened in the psychiatric, geriatric and emergency departments of la Rochelle and Rochefort secondary hospitals
Key inclusion criteria (2 listed)
- Attempted suicide and / or suicidal ideas
- Informed and agreed to participate
Key exclusion criteria (2 listed)
- Cognitive disorders
- Refusal to participate
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 |
|---|---|---|
| Post-suicidal crisis interviewProtective factor exploration during post-suicidal crisis interview | Behavioural | Suicide attempt or ideas |
Primary outcome
Number of outpatients (with a low to moderate risk of suicidal recurrence)
Time frame: 7 days
Based on risk, emergency and hazard, patients are classified as being at low, moderate and high risk of suicidal recurrence. Patients with low to moderate risk of suicidal recurrence are either inpatient or outpatient.
12 secondary outcomes
Number of patients considering themselves to be in good health
Time frame: 7 days
Number of patients considering that their physical or mental state did not alter their social life
Time frame: 7 days
Number of patients maintaining autonomy
Time frame: 7 days
Number of patients with religious practice
Time frame: 7 days
Number of patients with a sense of success and self-esteem
Time frame: 7 days
Number of patients considering their family environment to be satisfactory
Time frame: 7 days
Number of patients with at least one environmental protection factor
Time frame: 7 days
Number of patients with social protection factors
Time frame: 7 days
Number of patients able to adapt to difficult situations
Time frame: 7 days
Number of patients with extraversion capabilities
Time frame: 7 days
Number of patients with openness to others
Time frame: 7 days
Number of patients considering that their health has improved
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Inclusion difficulties, Investigator lack of time for the study completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 23666286Richard-Devantoy S, Jollant F. [Suicide in the elderly: age-related specificities?]. Sante Ment Que. 2012 Autumn;37(2):151-73. doi: 10.7202/1014949ar. French.
- Background: PubMed 18439452Conwell Y, Thompson C. Suicidal behavior in elders. Psychiatr Clin North Am. 2008 Jun;31(2):333-56. doi: 10.1016/j.psc.2008.01.004.
- Background: PubMed 12684581Casadebaig F, Ruffin D, Philippe A. [Suicide in the elderly at home and in retirement homes in France]. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):55-64. French.
- Epidemiology of suicide in FranceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Karine REISS, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
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 Suicide, Attempted and Suicide Gesture, run by Groupe Hospitalier de la Rochelle Ré Aunis 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 2 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: stopped early, as of the sponsor's last update on 5 Jul 2019. 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 was stopped early (reason given: Inclusion difficulties, Investigator lack of time for the study completion). 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?
Number of outpatients (with a low to moderate risk of suicidal recurrence) (time frame: 7 days). 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 NCT03162744, which also lists 3 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 5 Jul 2019.