Bezpečnostní plánování 6+ (HSI)
5. srpna 2026 aktualizováno: VA Office of Research and Development
Veteran-Centered, ED na bázi smrtelných prostředků Safety Suicide Prevention Intervention (CDA 19-076)
Přístup k smrtelným metodám sebepoškozování, jako jsou střelné zbraně a léky, zvyšuje riziko sebevraždy.
Pokyny VA/DoD pro péči o jedince se zvýšeným rizikem sebevraždy jako takové zahrnují doporučení, aby lékaři provedli intervence ke snížení přístupu k letálním metodám sebevražd u pacientů, u kterých bylo zjištěno zvýšené riziko sebevražd.
Nebyly však vyvinuty ani testovány žádné intervence mezi veterány hledajícími naléhavou péči – populací, u níž bylo dříve zjištěno zvýšené riziko.
Cílem této studie je pilotně otestovat smrtící prostředky bezpečnostní intervence vyvinuté speciálně pro veterány, kteří vyhledávají péči na pohotovostních odděleních VHA a zařízeních urgentní péče a je u nich zjištěno zvýšené riziko sebevražd.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
Vyšetřovatelé budou pilotovat zásah LMS založený na ED mezi až 50 veterány, aby posoudili proveditelnost a přijatelnost.
Typ studie
Intervenční
Zápis (Aktuální)
40
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Colorado
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Aurora, Colorado, Spojené státy, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
Setkání na VHA ED nebo v zařízení urgentní péče
->17 let
- Propuštěn domů z ED (spíše než přijetí do nemocnice)
- Riziko sebevraždy je na základě výsledků CSRE stanoveno jako střední nebo vysoké
- Pacient se rozhodne přezkoumat nový nebo aktualizovaný bezpečnostní plán jako součást své klinické péče
- Pacientem hlášený přístup ke střelným zbraním a/nebo lékům
Kritéria vyloučení:
- Neschopnost vyjádřit souhlas kvůli kognitivním poruchám, závažnosti onemocnění (včetně psychiatrických symptomů), intoxikaci drogami a/nebo alkoholem
- Nespolehlivý telefonní přístup
- Ti, kteří v současné době zažívají nechráněné bezdomovectví
- Žádná poštovní adresa
- Porucha aktivního užívání opioidů nebo stimulantů
- Porucha aktivního užívání alkoholu s každodenní konzumací alkoholu
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Intervention arm
There is a single intervention arm with no comparator for this pilot study.
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Tato intervence zahrnuje bezpečnostní intervenci v domácnosti, kterou provádí intervenční specialista se specifickým školením v usnadňování diskusí o bezpečnosti smrtících prostředků a poskytování bezplatných bezpečnostních zařízení pro léky a střelné zbraně.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Feasibility: Number of Participants Recruited Within One Year
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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:
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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
Časové okno: 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
Časové okno: 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:
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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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Average Participant Trust in the VA Healthcare System
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day of intervention delivery (day 0) and at 4 weeks
|
"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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day of intervention delivery (day 0) and at 4 weeks
|
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
Časové okno: Day of intervention delivery (day 0) and at 4 weeks
|
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
Časové okno: Day of intervention delivery (day 0) and at 4 weeks
|
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
Časové okno: Day of intervention delivery (day 0) and at 4 weeks
|
"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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
8. října 2024
Primární dokončení (Aktuální)
18. července 2025
Dokončení studie (Aktuální)
18. srpna 2025
Termíny zápisu do studia
První předloženo
20. prosince 2023
První předloženo, které splnilo kritéria kontroly kvality
10. ledna 2024
První zveřejněno (Aktuální)
22. ledna 2024
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
28. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CDX 24-001
- 1IK2HX002861-01A2 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .