Suicide, AttemptedNCT03043040
Prevention of Suicidal Behaviour With Telemedicine Techniques
A study testing Telephone follow up and Treatment as usual in people with Suicide, Attempted, run by Osakidetza.
Trial summary
This is a multicenter controlled intervention study that aims to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in adults discharged from general hospitals after a suicide attempt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Telephone follow up and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 31 Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients discharged from a General Hospital after a suicide attempt and who live in the same health sector as the hospital.
- The suicide attempt must have been made within 24 hours prior to the appointment in the Emergency Service.
Who cannot join
- Patient with severe cognitive difficulties and in general any self-injury in which the patient does not understand the meaning or potential consequences of such behavior.
- Patients in which a regular telephone contact is not possible.
- Patients in which the psychiatrist who evaluates the case deems inappropriate their inclusion.
- Patients who remain hospitalized 6 months after the attempt.
About this study
Official title: Prevention of Suicidal Behaviour in High Risk Patients With Telemedicine Techniques
This is a multicenter controlled intervention study that aims to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in adults discharged from general hospitals after a suicide attempt.
The hypothesis is that the implementation of this program is associated with reduced rates of suicide reattempts in these patients and also with delayed reattempts in them.
Read the detailed description
Justification: Suicide is a global public health concern and is the leading cause of avoidable death in the Basque Country (Spain). The use of telemedicine techniques applied to high risk patients has shown to be useful in the prevention of suicide and suicidal behavior.
Objectives: To assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in patients who recently attempted suicide.
Design: This is a multicenter, prospective intervention study, non-randomized and with control group.
Method: A sample of adults discharged from 2 general hospitals after a suicide attempt are enrolled in a telephone follow-up program which is added to their usual treatment (TAU). The program consists of 5 short calls made by nurses during 6 months. The calls are intended to: 1) Assess the risk of suicide in that moment, 2) Improve patient's adherence to treatments, and 3) Provide general psychoeducation guidelines. The control group is composed of patients discharged from a third general hospital after a suicide attempt. These receive TAU but are not enrolled in the telephone follow-up.
Evaluation: All patients are followed during 12 months. Main outcome measures include the percentage of patients that make a second attempt and the average time to reattempt.
Patients sign and informed consent.
- Conditions
- Suicide, Attempted
- Being tested
- Telephone follow up, Treatment as usual
- Keywords
- suicide, attempted, prevention, telemedicine
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone follow upBehavioural
Already described in previous page
Treatment as usualBehavioural
Already described in previous page
| Study group | Role | What they receive |
|---|---|---|
| Telephone follow up | Experimental | Patients discharged from hospital A and B after a suicide attempt receive a protocolized telephone follow which is added to their usual treatment (TAU). Calls are made by nurses at weeks 1,2,4,12 and 24 after the index suicide attempt.
TAU: Includes whatever treatment the doctor decides to offer to that patient (psychopharmacology, psychotherapy etc). Receives: Behavioral: Telephone follow up; Behavioral: Treatment as usual |
| Control | Active comparator | Patients discharged from hospital C after a suicide attempt receive treatment as usual (whatever treatment the doctor decides to offer to that patient: psychopharmacology, psychotherapy etc). Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in each group that make a second attempt
(Included in the title)
Measured: 0-12 months
Secondary outcomes (3)
Average number of days from the first attempt to the second, in each group
(Included in the title)
Measured: 0-12 months
Mean number of reattempts in each group
(Included in the title)
Measured: 0-12 months
Percentage of participants in each group requiring hospitalization after the suicide attempt
(Included in the title)
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jul 2014
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized non-blinded multicenter intervention study with control group. Patients from hospital A and B are included in the intervention group. Patients from hospital C are included in the control group.
- Masking
- None (open label)
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osakidetza
- Sponsor type
- University, hospital or other
- Collaborators
- Eusko Jaurlaritza
- Responsible party
- Principal investigator, Andrea Gabilondo, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043040
- Sponsor's protocol ID
- 2017AG01
- Status last verified
- Apr 2018
- First submitted
- 31 Jan 2017
- Last updated
- 9 Apr 2018
- 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 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Suicidal Behaviour in High Risk Patients With Telemedicine Techniques
- ClinicalTrials.gov ID
- NCT03043040
- Acronym / sponsor ID
- 2017AG01
- Conditions
- Suicide, Attempted
- Keywords
- suicide, attempted, prevention, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- OsakidetzaUniversity, hospital or other
- Collaborators
- Eusko Jaurlaritza
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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.
This is a multicenter controlled intervention study that aims to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in adults discharged from general hospitals after a suicide attempt.
The hypothesis is that the implementation of this program is associated with reduced rates of suicide reattempts in these patients and also with delayed reattempts in them.
Detailed description
Justification: Suicide is a global public health concern and is the leading cause of avoidable death in the Basque Country (Spain). The use of telemedicine techniques applied to high risk patients has shown to be useful in the prevention of suicide and suicidal behavior.
Objectives: To assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in patients who recently attempted suicide.
Design: This is a multicenter, prospective intervention study, non-randomized and with control group.
Method: A sample of adults discharged from 2 general hospitals after a suicide attempt are enrolled in a telephone follow-up program which is added to their usual treatment (TAU). The program consists of 5 short calls made by nurses during 6 months. The calls are intended to: 1) Assess the risk of suicide in that moment, 2) Improve patient's adherence to treatments, and 3) Provide general psychoeducation guidelines. The control group is composed of patients discharged from a third general hospital after a suicide attempt. These receive TAU but are not enrolled in the telephone follow-up.
Evaluation: All patients are followed during 12 months. Main outcome measures include the percentage of patients that make a second attempt and the average time to reattempt.
Patients sign and informed consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized non-blinded multicenter intervention study with control group. Patients from hospital A and B are included in the intervention group. Patients from hospital C are included in the control group.
| Arm | Type | Receives |
|---|---|---|
| Telephone follow up | Experimental | Behavioral: Telephone follow up, Behavioral: Treatment as usualPatients discharged from hospital A and B after a suicide attempt receive a protocolized telephone follow which is added to their usual treatment (TAU). Calls are made by nurses at weeks 1,2,4,12 and 24 after the index suicide attempt. TAU: Includes whatever treatment the doctor decides to offer to that patient (psychopharmacology, psychotherapy etc). |
| Control | Active comparator | Behavioral: Treatment as usualPatients discharged from hospital C after a suicide attempt receive treatment as usual (whatever treatment the doctor decides to offer to that patient: psychopharmacology, psychotherapy etc). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients discharged from a General Hospital after a suicide attempt and who live in the same health sector as the hospital.
- The suicide attempt must have been made within 24 hours prior to the appointment in the Emergency Service.
Key exclusion criteria (4 listed)
- Patient with severe cognitive difficulties and in general any self-injury in which the patient does not understand the meaning or potential consequences of such behavior.
- Patients in which a regular telephone contact is not possible.
- Patients in which the psychiatrist who evaluates the case deems inappropriate their inclusion.
- Patients who remain hospitalized 6 months after the attempt.
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 |
|---|---|---|
| Telephone follow upAlready described in previous page | Behavioural | Telephone follow up |
| Treatment as usualAlready described in previous page | Behavioural | Control, Telephone follow up |
Primary outcome
Percentage of participants in each group that make a second attempt
Time frame: 0-12 months
(Included in the title)
3 secondary outcomes
Average number of days from the first attempt to the second, in each group
Time frame: 0-12 months
Mean number of reattempts in each group
Time frame: 0-12 months
Percentage of participants in each group requiring hospitalization after the suicide attempt
Time frame: 0-12 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 9 Apr 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone follow up and Treatment as usual in people with Suicide, Attempted, run by Osakidetza.
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 4 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of participants in each group that make a second attempt (time frame: 0-12 months). 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 Apr 2018.