- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07620301
LLM Intervention for Tobacco in Underserved Populations (LIFT-UP) (LIFT-UP)
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.
This study 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lindsey Potter, MPH, PhD
- Número de teléfono: 801-213-6036
- Correo electrónico: lindsey.potter@hci.utah.edu
Ubicaciones de estudio
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84102
- Huntsman Cancer Institute/ University of Utah
-
Contacto:
- Lindsey Potter, MPH, PhD
- Número de teléfono: 801-213-6036
- Correo electrónico: lindsey.potter@hci.utah.edu
-
Investigador principal:
- Lindsey Potter, MPH, PhD
-
Investigador principal:
- Christian Mahony Reategui Rivera, MD, MS
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
System Usability Scale (SUS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Usability - Chat Bot Usability Scale (BUS-11)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah
- Investigador principal: Christian Mahony Reategui Rivera, MD, MS, University of Utah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HCI199440
- U54CA280812 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre LIFT-UP Chatbot
-
University of Maryland Eastern ShoreTerminadoComportamientos de riesgo para la salud | La inactividad físicaEstados Unidos
-
Zhen Jun WangPeking University Third Hospital; Beijing Luhe Hospital; Beijing Shuyi Hospital; The... y otros colaboradoresDesconocidoFístula anal | LIFT-tapón | Tasa de curación | Función analPorcelana
-
Assiut UniversityDesconocido
-
Rush University Medical CenterTerminadoFístula rectal | Fístula anal | Fístula en el ano | Fístula transesfinterianaEstados Unidos
-
Zhen Jun WangPeking University Third Hospital; Shaanxi Provincial People's Hospital; Tianjin... y otros colaboradoresDesconocidoFístula anorrectal | Alteración de la matriz extracelularPorcelana
-
University of California, San DiegoNational Institute on Drug Abuse (NIDA); Johns Hopkins University; RTI InternationalInscripción por invitaciónEstigma Social | VIH (Virus de Inmunodeficiencia Humana) | Abuso de drogas ilícitasKirguistán
-
ZKR Orthopedics IncReclutamientoArtrosis patelofemoralEstados Unidos
-
Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)TerminadoDesorden obsesivo compulsivo | Desórdenes de ansiedad | Trastorno de estrés postraumáticoEstados Unidos
-
Distrito Sanitario AlmeriaJunta de AndaluciaTerminadoSalud digital | Violencia en el trabajo | Profesionales de la salud | ChatbotEspaña
-
Shannon E. Sauer-ZavalaTerminadoDesorden depresivo | Desorden obsesivo compulsivo | Desórdenes de ansiedad | Trastorno de estrés postraumáticoEstados Unidos