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LLM Intervention for Tobacco in Underserved Populations (LIFT-UP) (LIFT-UP)

26 maggio 2026 aggiornato da: University of Utah

This study will test a tailored, multilingual tobacco cessation chatbot called LIFT-UP (LLM Intervention for Tobacco in Underserved Populations), designed to better meet the needs of people living in persistent poverty census tracts.

We will use 1:1 semi-structured interviews to explore social drivers of health impacting TC, as well as digital access and preferences among those living in PPCTs. This qualitative approach enables guided yet flexible exploration of key domains while capturing unanticipated insights relevant to refining the chatbot.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tobacco use is a major cause of cancer and is responsible for about half a million deaths in the United States each year. Because of this, helping people stop using tobacco is one of the most important ways to prevent cancer. Although tobacco use has decreased over time, many adults in the U.S. still use tobacco. Many people try to quit each year, but most quit attempts are not successful. One reason is that many people do not use proven, evidence-based quit support, such as counseling or quit medications.

People who live in areas with long-term poverty often face additional barriers that can make quitting harder. These areas may have fewer job and education opportunities, limited access to healthcare and community resources, and higher levels of day-to-day stress (for example, related to financial strain or lack of health insurance). People with lower income are just as likely to try to quit as those with higher income, but they are less likely to quit successfully and are less likely to use evidence-based quitting support. Many persistent poverty areas are also rural and have higher numbers of people who prefer to speak languages other than English, including Spanish, which creates an additional need for bilingual and culturally appropriate quit support.

Digital tools may help increase access to evidence-based tobacco cessation support in these communities. Mobile phone ownership is very common, including among people with lower incomes. However, some smartphone apps require reliable internet access or data plans, which can be a barrier. Text messaging is accessible on nearly all phones, does not require internet access, can be offered in multiple languages, and can be tailored to the needs of the user.

Text-based programs that use artificial intelligence (AI), such as large-language-model chatbots, may be especially useful because they can provide interactive support using natural language and can be delivered at scale. Chatbots have been used successfully in other areas of health, but many existing programs use fixed scripts and may not feel relevant or helpful for all groups. Importantly, most tobacco cessation chatbots have not been designed to address barriers faced by people living in persistent poverty areas.

Tipo di studio

Interventistico

Iscrizione (Stimato)

22

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84102
        • Huntsman Cancer Institute/ University of Utah
        • Contatto:
        • Investigatore principale:
          • Lindsey Potter, MPH, PhD
        • Investigatore principale:
          • Christian Mahony Reategui Rivera, MD, MS

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 18+ years old
  • Use ≥3 cigarettes/day on average
  • Motivated to quit in the next 30 days
  • Have a computer or tablet with internet access for 1:1 interviews
  • Speak English or Spanish
  • Home address is in an area characterized by persistent poverty

Exclusion Criteria:

  • None

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Moderated Session
Participants will attend a ~80 minute moderated "think-aloud" session via HIPAA compliant videoconferencing platform.
LIFT-UP Chatbot will be developed, evaluated, and refined using GARDE-Chat, an open-source chatbot authoring platform that has been used to support the development of chatbot-based interventions tested in large pragmatic clinical trials.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
System Usability Scale (SUS)
Lasso di tempo: up to 1 day

Usability will be measured using the SUS, a questionnaire assessing the perceived usability of a system, product, website, app, or digital intervention. It consists of ten 5-point Likert items ranging from "Strongly disagree" to "Strongly agree".

Scoring follows the standard SUS scoring procedure, for positively worded items, the item score is calculated as response minus 1; for negatively worded items, the item score is calculated as 5 minus the response. The 10 item scores are summed and then multiplied by 2.5 to generate the final SUS score, with higher scores indicating greater perceived usability. Score range: 0-100.

up to 1 day

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Usability - Chat Bot Usability Scale (BUS-11)
Lasso di tempo: up to 1 day
Chatbot usability will be measured using the Chatbot Usability Scale (BUS-11). BUS-11 is a measured that assesses users' experiences after interacting with a chatbot or conversational agent. The BUS-11 consists of eleven 5-point Likert items ranging from "Strongly disagree" to "Strongly agree". Each item is coded from 1 to 5, and item scores are summed to create a total score. Higher scores indicate greater perceived chatbot usability. Score range: 11-55.
up to 1 day
Acceptability
Lasso di tempo: up to 1 day
Acceptability will be measured using the Acceptability of Intervention Measure (AIM). AIM is an instrument that assesses the perceived acceptability of an intervention. It consists of four 5 point Likert items ranging from "Completely "disagree" to "Strongly agree". Each item is coded from 1 to 5, and the overall score is the mean of the items score. Higher scores indicate greater perceived acceptability of the intervention. Score range: 1-5.
up to 1 day
Digital Working Alliance
Lasso di tempo: up to 1 day
Working alliance in the digital context will be measured with the Digital Working Alliance inventory (D-WAI). D-WAI is derived from the Working Alliance Inventory and measures the perceived working alliance (e.g., traditionally the collaborative bond between therapist and client) with digital interventions. It includes six 7-point Likert items ranging from "Strongly disagree" to "Strongly agree". Each item is coded from 1 to 7, and item scores are summed to create a total score. Higher scores indicate a stronger perceived digital working alliance. Score range: 7-42.
up to 1 day
Perceived cultural fit
Lasso di tempo: up to 1 day
Perceived cultural relevance will be measured using the Cultural Relevance Questionnaire (CRQ). CRQ consists of six 5-point Likert items ranging from "Strongly disagree" to "Strongly agree. Higher scores indicate greater perceived cultural appropriateness/relevance of the intervention. Score range: 5-25. An additional 5-point Likert-like question was added to reflect overall cultural fit perceived by the users.
up to 1 day

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah
  • Investigatore principale: Christian Mahony Reategui Rivera, MD, MS, University of Utah

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 maggio 2027

Completamento dello studio (Stimato)

31 maggio 2027

Date di iscrizione allo studio

Primo inviato

26 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HCI199440
  • U54CA280812 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

De-identified data will be shared with only with investigators that have a data sharing agreement through PIVOT.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su LIFT-UP Chatbot

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