- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03643679
Tobacco Cessation for Sexual Minorities
There is a growing body of evidence revealing disproportionately higher rates of tobacco use among sexual and gender minority (SGM) individuals, compared to their heterosexual peers. These disparities have led organizations to support the inclusion of SGM in all local, state, and national tobacco prevention and control activities. In an attempt to leverage the online milieu for health-related interventions, mobile apps have been created to support tobacco cessation. However, evidence-based apps promoted by the National Cancer Institute are unpopular, remain poorly supported, and were not studied for use by SGM persons. Commercial apps, on the other hand, have been downloaded millions of times, contain many valuable features, and enjoy better infrastructure. Unfortunately, they are not evidence-based and have not been rigorously tested.
The University of Pittsburgh (Pitt) is currently conducting a randomized controlled trial to assess the feasibility and efficacy of using the Kwit tobacco cessation app with patients at UPMC Montefiore and Presbyterian hospitals (PI: Chu). It is a pragmatic clinical trial applying a patient-centered outcomes framework to ensure that-rather than focusing only on successful cessation-the study includes measurements for quality of life, mobility, and social interactions. We propose to extend the study to underrepresented SGM young adults.
Survey measures will be adapted as needed to address issues specific to the SGM population.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18-30
- Self-identified as a sexual minority (gay, lesbian, bisexual)
- Smokers interested in cessation (>1 cigarettes/day over the past 30 days)
- Must own an Apple or Android based smartphone.
Exclusion Criteria:
- Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Kwit smartphone app
This arm will receive the Kwit smartphone app.
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The Kwit smartphone app combines several popular features of tobacco cessation apps, including game-like features (e.g., unlocking achievement milestones for completing cessation-related tasks), useful statistics (e.g., money saved), and an ability to share progress with friends.
Users can actively engage with the app to track cravings or view progress, such as life expectancy gained.
A passive component notifies users when milestones have been achieved, e.g., when blood no longer contains nicotine.
Motivational messages can be actively requested at any time; they can also appear unsolicited, as when the user logs cravings.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Helpfulness, frequency of use, and ease of use of the intervention smartphone app
Periodo de tiempo: 1-month and 3-month
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Assessment of feasibility: Two follow-up surveys will be administered: the first, 1-month after recruitment,and the second, 3 months after recruitment. Surveys will be administered in-person. Specific questions will be asked to rate the Kwit smartphone application's feasibility, based on a combination of helpfulness, frequency of use, and ease of use. Frustrations and helpful aspects of the application will be assesses qualitatively.
Each of these responses (Q1-3) will be combined to report a single overall feasibility value. Qualitative data (Q4) will be used to modify scores as needed. |
1-month and 3-month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cessation (self-report)
Periodo de tiempo: 1-month and 3-month
|
Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via two follow-up surveys (1 month and 3 months after recruitment), with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.
The overall assessment of cessation will be primarily based on the 7-day item. |
1-month and 3-month
|
|
Cessation (bio-chemical)
Periodo de tiempo: 1-month and 3-month
|
Cessation will also be verified by a breath analysis monitor.
The information will be obtained during each follow-up.
Biochemical verification will be based on a 10 COppm cutoff to determine whether or not the participant has successfully quit tobacco.
|
1-month and 3-month
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- PRO18050656
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.
producto fabricado y exportado desde los 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 Kwit smartphone app
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Paris Nanterre UniversityTerminadoDejar de fumar | TCC | Compromiso | Modelo de aceptación de TecnologíaFrancia
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London School of Hygiene and Tropical MedicineTerminadoNutrición | Sostenibilidad | Tecnología de salud móvil (mHealth)Reino Unido
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University of MinnesotaAmerican Cancer Society, Inc.; Melanoma Research AllianceTerminadoMelanoma (piel)Estados Unidos
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Northwestern UniversityAmerican Cancer Society, Inc.TerminadoCáncer de mamaEstados Unidos
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Haukeland University HospitalWestern Norway University of Applied SciencesAún no reclutandoSalud digital | Búsqueda de ayuda de salud mental | ReadmisionesNoruega
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Brigham and Women's HospitalReclutamientoInfección de heridas y cicatrización de heridasEstados Unidos
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Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Stanford...TerminadoActividad físicaEstados Unidos
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Ministry of Science and Technology, TaiwanFu Jen Catholic UniversityReclutamientoCondiciones Infantiles | Amamantamiento | Ansiedad pospartoTaiwán
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Research Center for Clinical Neuroimmunology and...Hoffmann-La Roche; Novartis Pharmaceuticals; University Hospital, Basel, Switzerland y otros colaboradoresActivo, no reclutando
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University of Electronic Science and Technology...ReclutamientoTrastorno del espectro autista de alto funcionamientoPorcelana