SuicideHSINCT06216327
Home Safety Intervention
A study testing household safety intervention in people with Suicide and Firearm Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Access to lethal methods of self-harm such as firearms and medications increases risk for suicide. As such, VA/DoD guidelines for the care of individuals with elevated suicide risk include recommendations that clinicians deliver interventions to reduce access to lethal methods of suicide among patients who are… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Suicide, Firearm Injury, Overdose
- What is being tested?
- household safety intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Encounter at VHA ED or urgent care setting, outpatient mental health, women's health, or primary care
- >17 years
- Discharged home from the encounter (rather than hospital admission)
- Positive Columbia Screener
- Patient-reported access to self-owned firearms and/or medications
Who cannot join
- Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
- Unreliable telephone access
- Unreliable video access (because remote intervention)
- Those currently experiencing unsheltered homelessness
- No mailing address
- Active opioid or stimulant use disorder
- Active alcohol use disorder with daily alcohol consumption
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
About this study
Official title: Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
Access to lethal methods of self-harm such as firearms and medications increases risk for suicide. As such, VA/DoD guidelines for the care of individuals with elevated suicide risk include recommendations that clinicians deliver interventions to reduce access to lethal methods of suicide among patients who are identified as having elevated suicide risk. However, no interventions have been developed or tested among Veterans with elevated suicide risk. The aim of this study is to pilot test a lethal means safety intervention developed specifically for Veterans who seek care in VHA clinical settings and are identified as having elevated suicide risk.
Read the detailed description
The investigators will pilot the LMS intervention among up to 50 Veterans to assess feasibility and acceptability. The study was suspended from April to June 2024 due to low study enrollment; modification of recruitment procedures and study approach.
- Conditions
- Suicide, Firearm Injury, Overdose
- Being tested
- household safety intervention
- Keywords
- firearm
- Medical subject headings
- Suicide, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
household safety interventionBehavioural
This intervention includes a household safety intervention that is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | There is a single intervention arm with no comparator for this pilot study. Receives: Behavioral: household safety intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Number of Participants Recruited Within One Year
Ability to recruit 40 Veterans in one year. Count represents number of participants recruited within one year.
Measured: through study completion, an average of one year
Feasibility: Number of Participants Who Attend Their 4 Week Follow Up
>80% of participants attend their 4 week follow up. Count represents number of participants who completed their 4 week follow up visit.
Measured: approximately 4 weeks
Acceptability: Number of Participants With CSQ Scores ≥24
>80% with score greater than 23 (Client Satisfaction Questionnaire 8). 8 items, each with 4 answer options (1-4) on a Likert Scale. Likert options are different for each item. Score range is 8 to 32. Higher scores indicate higher satisfaction.
Measured: day of intervention delivery - day 0; and at 4 weeks
Acceptability: Number of Participants Who Reported the Intervention to be Acceptable
Count of participants who deemed the intervention acceptable via a qualitative evaluation of participant's experiences during the intervention. Assessed using the Narrative Evaluation of Intervention Interview (NEII): A 16-item semi-structured qualitative interview that helps participants evaluate the process and outcome of interventions.
Measured: at 4 weeks
Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable
Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable".
"How comfortable did you feel engaging in the discussion?"
Likert responses:
- Very uncomfortable
- Uncomfortable
- Neither
- Comfortable
- Very comfortable
Measured: day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions
Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful".
"How helpful was your interaction in making decisions about medication storage and safety?"
Likert responses:
- Not at all
- Slightly helpful
- Moderately helpful
- Very helpful
- Extremely helpful
Measured: day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions
Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful".
"How helpful was your interaction in making decisions about firearm storage?"
Likert responses:
- Not at all
- Slightly helpful
- Moderately helpful
- Very helpful
- Extremely helpful
Measured: day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners
Count represents the number of participants who reported that their interaction was "Respectful" or "Very respectful".
"To what extent was this intervention respectful of your values as a firearm owner?
Likert responses:
- Very disrespectful
- Disrespectful
- Neither
- Respectful
- Very respectful
Measured: day of intervention delivery - day 0; and at 4 weeks
Secondary outcomes (20)
Average Participant Trust in the VA Healthcare System
"On a scale from 0 to 10, where 10 indicates complete trust and 0 indicates complete distrust (so 5 would indicate that you neither trust, nor distrust), Please indicate your level of trust in the VA healthcare system?" Answer range: 0-10
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is important to securely store medications when I or someone in my household has had recent thoughts of suicide." Answer range: 0-10
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Medication Storage Always
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to securely store medications even if someone is not at risk for suicide in the home." Answer range: 0-10
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is important to securely store firearms when I or someone in my household has had recent thoughts of suicide." Answer range: 0-10
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Firearm Storage Always
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to store firearms securely in a locked space, or with a locking device, even if someone is not at risk for suicide in the home." Answer range: 0-10
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Unloaded Firearm Storage Always
"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to securely store firearms unloaded even if someone is not at risk for suicide in the home." Answer range: 0-10
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Readiness to Securely Store All Firearms
"One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all firearms. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10
Measured: Day of intervention delivery - day 0
Average Participant Readiness to Securely Store All Medications
"One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all medications. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change]?" Answer range: 0-10
Measured: Day of intervention delivery at visit #1 (day 0)
Average Number of Firearms in Household
Number of firearms in household: Answer range: 0 to 10,000
Measured: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Who Forget to Take Their Medications Often/Always
Count represents number of participants who said 'very often' or 'always'. "To what extent have you had difficulty remembering to take your medications in the past month?"
Likert responses:
- Never
- Rarely
- Sometimes
- Very Often
- Always
Measured: at 4 weeks
Number of Participants With Firearms Present in the Home
Changes in whether household firearms are present in a participant's home from day of intervention delivery (day 0) to 4 weeks. Count represents the number of participants who reported having at least 1 firearm in their home.
Measured: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Firearms
Changes in whether household firearms are stored securely. Count represents number of participants who had 'all' firearms locked.
"Are any firearms in or around your home currently stored locked?"
Answers:
- Yes, all of them are locked
- Yes, some of them are locked
- None of them are locked
- I'm not sure
- Decline to respond
Measured: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Medications
Changes in whether present medication are all stored securely. Count represents the number of participants who stored 'all' of their medications locked.
"Are the medications in your home currently stored locked? (Examples include using a locked cabinet or box)"
Answer options:
- Yes, all of the medications in my home are locked up
- Yes, some of the medications in my home are locked up
- None of the medications in my home are locked up
- I'm not sure
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Importance of Firearm Ownership for Protection
"On a scale of 0 to 10, to what extent do you keep your firearms to protect yourself or your loved ones from other people? Someone who answers 0 does not consider themselves to keep firearms for protection, while someone who answers 10 considers that their firearms are absolutely required for protection." Answer range: 0-10
Measured: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust
"One of the safest things someone can do while they're going through a difficult time is to store their firearms outside of the home with someone they trust. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10
Measured: Day of intervention delivery (day 0)
Number of Participants Who Do Not Have Access to Locked Firearm(s)
Count of people who said they do not have access to the key/combination for their locked firearm.
"For the firearms in your home that are locked, who has access to the keys or number combinations that would be needed to access them?"
Answer options:
- You
- Your spouse or partner
- Children under the age of 18 years
- Children 18 years of age or older
- A friend
- A neighbor
- Other:__________
Measured: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Ammunition in the Home
Changes from day of intervention delivery (day 0) to 4 weeks in whether household ammunition is present. The presence of ammunition in the home was only asked to participants who stated there were firearms in the home and that they were the owner of at least 1 of the firearms in the home. Count represents number of participants who reported having ammunition in the home.
Measured: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With All Ammunition Locked
Count of participants who reported having 'all' ammunition in the home securely locked. This measure was only asked to participants who reported that there were firearms in the home, that they were the owner of at least 1 of the firearms in the home, and that there was ammunition in the home.
"Is ammunition in or around your home currently stored in a locked place, such as a locked cabinet?"
Answer options:
- Yes, all of the ammunition is locked
- Yes, some of the ammunition is locked
- None of the ammunition is locked
- I'm not sure
- No ammunition is in my home
Measured: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Naloxone Prescription in Participant Electronic Health Record
Count of participants who have a naloxone prescription (yes/no). Verified through each participant's electronic health record.
Measured: at 8 weeks
Number of Participants With Verified Return of Medication Safety Envelope
Verification of returned medication safety envelope (yes/no). Count represents number of participants who utilized their medication return envelope.
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start8 Oct 2024
- Primary completion18 Jul 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This intervention includes a household safety intervention that is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph A Simonetti, MD MPH, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216327
- Sponsor's protocol ID
- CDX 24-001
- Other IDs
- 1IK2HX002861-01A2
- Acronym
- HSI
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2023
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
- ClinicalTrials.gov ID
- NCT06216327
- Acronym / sponsor ID
- HSI / CDX 24-001
- Conditions
- Suicide, Firearm Injury, Overdose
- Keywords
- firearm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Access to lethal methods of self-harm such as firearms and medications increases risk for suicide. As such, VA/DoD guidelines for the care of individuals with elevated suicide risk include recommendations that clinicians deliver interventions to reduce access to lethal methods of suicide among patients who are identified as having elevated suicide risk. However, no interventions have been developed or tested among Veterans with elevated suicide risk. The aim of this study is to pilot test a lethal means safety intervention developed specifically for Veterans who seek care in VHA clinical settings and are identified as having elevated suicide risk.
Detailed description
The investigators will pilot the LMS intervention among up to 50 Veterans to assess feasibility and acceptability. The study was suspended from April to June 2024 due to low study enrollment; modification of recruitment procedures and study approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This intervention includes a household safety intervention that is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: household safety interventionThere is a single intervention arm with no comparator for this pilot study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Encounter at VHA ED or urgent care setting, outpatient mental health, women's health, or primary care
- >17 years
- Discharged home from the encounter (rather than hospital admission)
- Positive Columbia Screener
- Patient-reported access to self-owned firearms and/or medications
Key exclusion criteria (7 listed)
- Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
- Unreliable telephone access
- Unreliable video access (because remote intervention)
- Those currently experiencing unsheltered homelessness
- No mailing address
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 |
|---|---|---|
| household safety interventionThis intervention includes a household safety intervention that is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms. | Behavioural | Intervention arm |
Primary outcome
Feasibility: Number of Participants Recruited Within One Year
Time frame: through study completion, an average of one year
Ability to recruit 40 Veterans in one year. Count represents number of participants recruited within one year.
Feasibility: Number of Participants Who Attend Their 4 Week Follow Up
Time frame: approximately 4 weeks
>80% of participants attend their 4 week follow up. Count represents number of participants who completed their 4 week follow up visit.
Acceptability: Number of Participants With CSQ Scores ≥24
Time frame: day of intervention delivery - day 0; and at 4 weeks
>80% with score greater than 23 (Client Satisfaction Questionnaire 8). 8 items, each with 4 answer options (1-4) on a Likert Scale. Likert options are different for each item. Score range is 8 to 32. Higher scores indicate higher satisfaction.
Acceptability: Number of Participants Who Reported the Intervention to be Acceptable
Time frame: at 4 weeks
Count of participants who deemed the intervention acceptable via a qualitative evaluation of participant's experiences during the intervention. Assessed using the Narrative Evaluation of Intervention Interview (NEII): A 16-item semi-structured qualitative interview that helps participants evaluate the process and outcome of interventions.
Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable
Time frame: day of intervention delivery - day 0; and at 4 weeks
Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable". "How comfortable did you feel engaging in the discussion?" Likert responses: * Very uncomfortable * Uncomfortable * Neither * Comfortable * Very comfortable
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions
Time frame: day of intervention delivery - day 0; and at 4 weeks
Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful". "How helpful was your interaction in making decisions about medication storage and safety?" Likert responses: * Not at all * Slightly helpful * Moderately helpful * Very helpful * Extremely helpful
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions
Time frame: day of intervention delivery - day 0; and at 4 weeks
Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful". "How helpful was your interaction in making decisions about firearm storage?" Likert responses: * Not at all * Slightly helpful * Moderately helpful * Very helpful * Extremely helpful
Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners
Time frame: day of intervention delivery - day 0; and at 4 weeks
Count represents the number of participants who reported that their interaction was "Respectful" or "Very respectful". "To what extent was this intervention respectful of your values as a firearm owner? Likert responses: * Very disrespectful * Disrespectful * Neither * Respectful * Very respectful
20 secondary outcomes
Average Participant Trust in the VA Healthcare System
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Medication Storage Always
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Secure Firearm Storage Always
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Beliefs About Importance of Unloaded Firearm Storage Always
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Readiness to Securely Store All Firearms
Time frame: Day of intervention delivery - day 0
Average Participant Readiness to Securely Store All Medications
Time frame: Day of intervention delivery at visit #1 (day 0)
Average Number of Firearms in Household
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Who Forget to Take Their Medications Often/Always
Time frame: at 4 weeks
Number of Participants With Firearms Present in the Home
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Firearms
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Medications
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Importance of Firearm Ownership for Protection
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust
Time frame: Day of intervention delivery (day 0)
Number of Participants Who Do Not Have Access to Locked Firearm(s)
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Ammunition in the Home
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With All Ammunition Locked
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Naloxone Prescription in Participant Electronic Health Record
Time frame: at 8 weeks
Number of Participants With Verified Return of Medication Safety Envelope
Time frame: at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joseph A Simonetti, MD MPH principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing household safety intervention in people with Suicide and Firearm Injury, run by VA Office of Research and Development at 1 site in United States.
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 7 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 28 Aug 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility: Number of Participants Recruited Within One Year (time frame: through study completion, an average of one year). The study lists 8 primary outcomes in all. 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 28 Aug 2026.