Veiligheidsplanning 6+ (HSI)
5 augustus 2026 bijgewerkt door: VA Office of Research and Development
Veteranengerichte, op ED gebaseerde dodelijke middelen Veiligheid zelfmoordpreventie-interventie (CDA 19-076)
Toegang tot dodelijke methoden voor zelfbeschadiging, zoals vuurwapens en medicijnen, verhoogt het risico op zelfmoord.
Als zodanig omvatten de VA/DoD-richtlijnen voor de zorg voor personen met een verhoogd zelfmoordrisico aanbevelingen dat artsen interventies uitvoeren om de toegang tot dodelijke zelfmoordmethoden te verminderen bij patiënten bij wie is vastgesteld dat ze een verhoogd zelfmoordrisico hebben.
Er zijn echter geen interventies ontwikkeld of getest onder veteranen die spoedeisende hulp zoeken – een populatie waarvan eerder werd vastgesteld dat deze een verhoogd risico liep.
Het doel van deze studie is het testen van een dodelijke veiligheidsinterventie die specifiek is ontwikkeld voor veteranen die zorg zoeken op de VHA-spoedeisende hulpafdelingen en spoedeisende zorginstellingen en bij wie is vastgesteld dat ze een verhoogd zelfmoordrisico hebben.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
De onderzoekers zullen de ED-gebaseerde LMS-interventie testen onder maximaal 50 veteranen om de haalbaarheid en aanvaardbaarheid te beoordelen.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
Ontmoeting op VHA ED of spoedeisende zorg
->17 jaar
- Naar huis ontslagen van de spoedeisende hulp (in plaats van ziekenhuisopname)
- Op basis van de CSRE-resultaten wordt vastgesteld dat het zelfmoordrisico gemiddeld of hoog is
- De patiënt kiest ervoor om een nieuw of bijgewerkt veiligheidsplan te beoordelen als onderdeel van zijn klinische zorg
- Door de patiënt gerapporteerde toegang tot vuurwapens en/of medicijnen
Uitsluitingscriteria:
- Kan geen toestemming geven vanwege cognitieve stoornissen, ernst van de ziekte (inclusief psychiatrische symptomen), intoxicatie met drugs en/of alcohol
- Onbetrouwbare telefoonverbinding
- Degenen die momenteel onbeschermde dakloosheid ervaren
- Geen postadres
- Actieve stoornis in het gebruik van opioïden of stimulerende middelen
- Actieve alcoholgebruiksstoornis met dagelijks alcoholgebruik
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
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Deze interventie omvat een interventie voor de veiligheid van het huishouden die wordt gegeven door een interventionist met een specifieke training in het faciliteren van veiligheidsdiscussies over dodelijke middelen, en het verstrekken van gratis veiligheidsvoorzieningen voor medicijnen en vuurwapens.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility: Number of Participants Recruited Within One Year
Tijdsspanne: through study completion, an average of one year
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Ability to recruit 40 Veterans in one year.
Count represents number of participants recruited within one year.
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through study completion, an average of one year
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Feasibility: Number of Participants Who Attend Their 4 Week Follow Up
Tijdsspanne: approximately 4 weeks
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>80% of participants attend their 4 week follow up.
Count represents number of participants who completed their 4 week follow up visit.
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approximately 4 weeks
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Acceptability: Number of Participants With CSQ Scores ≥24
Tijdsspanne: day of intervention delivery - day 0; and at 4 weeks
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>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.
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day of intervention delivery - day 0; and at 4 weeks
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Acceptability: Number of Participants Who Reported the Intervention to be Acceptable
Tijdsspanne: at 4 weeks
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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.
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at 4 weeks
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Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable
Tijdsspanne: day of intervention delivery - day 0; and at 4 weeks
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Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable". "How comfortable did you feel engaging in the discussion?" Likert responses:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions
Tijdsspanne: 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:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions
Tijdsspanne: day of intervention delivery - day 0; and at 4 weeks
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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:
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day of intervention delivery - day 0; and at 4 weeks
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Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners
Tijdsspanne: day of intervention delivery - day 0; and at 4 weeks
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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:
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day of intervention delivery - day 0; and at 4 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Average Participant Trust in the VA Healthcare System
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Medication Storage Always
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Secure Firearm Storage Always
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Beliefs About Importance of Unloaded Firearm Storage Always
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Readiness to Securely Store All Firearms
Tijdsspanne: Day of intervention delivery - day 0
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"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
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Day of intervention delivery - day 0
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Average Participant Readiness to Securely Store All Medications
Tijdsspanne: Day of intervention delivery at visit #1 (day 0)
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"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
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Day of intervention delivery at visit #1 (day 0)
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Average Number of Firearms in Household
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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Number of firearms in household: Answer range: 0 to 10,000
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Who Forget to Take Their Medications Often/Always
Tijdsspanne: at 4 weeks
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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:
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at 4 weeks
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Number of Participants With Firearms Present in the Home
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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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.
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Securely Storing All Firearms
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants Securely Storing All Medications
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Average Importance of Firearm Ownership for Protection
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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"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
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Day of intervention delivery (day 0) and at 4 weeks
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Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust
Tijdsspanne: Day of intervention delivery (day 0)
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"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
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Day of intervention delivery (day 0)
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Number of Participants Who Do Not Have Access to Locked Firearm(s)
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With Ammunition in the Home
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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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.
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With All Ammunition Locked
Tijdsspanne: Day of intervention delivery (day 0) and at 4 weeks
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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:
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Day of intervention delivery (day 0) and at 4 weeks
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Number of Participants With Naloxone Prescription in Participant Electronic Health Record
Tijdsspanne: at 8 weeks
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Count of participants who have a naloxone prescription (yes/no).
Verified through each participant's electronic health record.
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at 8 weeks
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Number of Participants With Verified Return of Medication Safety Envelope
Tijdsspanne: at 8 weeks
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Verification of returned medication safety envelope (yes/no).
Count represents number of participants who utilized their medication return envelope.
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at 8 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 oktober 2024
Primaire voltooiing (Werkelijk)
18 juli 2025
Studie voltooiing (Werkelijk)
18 augustus 2025
Studieregistratiedata
Eerst ingediend
20 december 2023
Eerst ingediend dat voldeed aan de QC-criteria
10 januari 2024
Eerst geplaatst (Werkelijk)
22 januari 2024
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
5 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CDX 24-001
- 1IK2HX002861-01A2 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .