Mixed and Match vs One-size-fits-all
22 de marzo de 2022 actualizado por: Dr Katherine Lam, The Hong Kong Polytechnic University
Mixed and Match Versus One-size-fits-all: A Randomized Controlled Trial of Self-determination Theory on a Menu of Smoking Cessation Options (SDTM) Among Adult Smokers
Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation.
While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness.
This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
A randomized controlled trial (RCT) will be conducted.
One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong.
Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline.
Participants can choose to receive their own smoking cessation treatment options from our menu.
Control group participants will only receive a self-help quitting leaflet
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
500
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Katherine Lam, PhD
- Número de teléfono: 27666420
- Correo electrónico: kwkatlam@polyu.edu.hk
Copia de seguridad de contactos de estudio
- Nombre: Eva Ho, PhD
- Número de teléfono: 27666417
- Correo electrónico: kyeva.ho@polyu.edu.hk
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
25 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- have smoking in the previous 30 days.
- be above 25 years old
- able to speak Cantonese and read Chinese
Exclusion Criteria:
- who are receiving current smoking cessation services
- report psychological disorders
- at risk of suicide
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Mixed and Match
Participants can choose to receive their own smoking cessation treatment options from our menu.
|
Participants will receive a brief 15-minute counselling session based on the 5A's' and '5R's' models by our trained research assistant.
Participants will be able to choose their smoking cessation treatment options from our menu.
|
|
Otro: Control
Participants will receive a self-help quitting leaflet
|
Participants in the control group will receive a self-help quitting leaflet issued by the TACO
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-reported abstinence at 6-month follow-up
Periodo de tiempo: At 6-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 6-month follow-up
|
|
Biochemically validated abstinence
Periodo de tiempo: At 6 months follow-up
|
validate the self-reported abstinence if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests
|
At 6 months follow-up
|
|
Self-efficacy at 6-month follow-up
Periodo de tiempo: At 6-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
At 6-month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Screening rate
Periodo de tiempo: at day 1
|
calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
|
at day 1
|
|
Eligibility rate
Periodo de tiempo: at day 1
|
calculated by dividing the number of smokers who are eligible by the number who are screened.
|
at day 1
|
|
Randomization rate
Periodo de tiempo: at day 1
|
calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent.
|
at day 1
|
|
Attendance rate
Periodo de tiempo: Immediately after the training workshop
|
calculated by dividing the number of smokers who complete the intervention by those who are randomized.
|
Immediately after the training workshop
|
|
Retention rate at 1-week follow-up
Periodo de tiempo: At 1-week follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 1-week follow-up
|
|
Retention rate at 1-month follow-up
Periodo de tiempo: At 1-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 1-month follow-up
|
|
Retention rate at 6-month follow-up
Periodo de tiempo: At 6-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 6-month follow-up
|
|
Retention rate at 3-month follow-up
Periodo de tiempo: At 3-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 3-month follow-up
|
|
Adherence to intervention protocol at 1-week follow-up
Periodo de tiempo: At 1-week follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 1-week follow-up
|
|
Adherence to intervention protocol at 1-month follow-up
Periodo de tiempo: At 1-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 1-month follow-up
|
|
Adherence to intervention protocol at 3-month follow-up
Periodo de tiempo: At 3-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 3-month follow-up
|
|
Adherence to intervention protocol at 6-month follow-up
Periodo de tiempo: At 6-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 6-month follow-up
|
|
Complete rate at 1-week follow-up
Periodo de tiempo: At 1-week follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 1-week follow-up
|
|
Complete rate at 1-month follow-up
Periodo de tiempo: At 1-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 1-month follow-up
|
|
Complete rate at 3-month follow-up
Periodo de tiempo: At 3-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 3-month follow-up
|
|
Complete rate at 6-month follow-up
Periodo de tiempo: At 6-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 6-month follow-up
|
|
Missing data at 1-week follow-up
Periodo de tiempo: At 1-week follow-up
|
calculated as the percentage of missing values in the dataset
|
At 1-week follow-up
|
|
Missing data at 1-month follow-up
Periodo de tiempo: At 1-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 1-month follow-up
|
|
Missing data at 3-month follow-up
Periodo de tiempo: At 3-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 3-month follow-up
|
|
Missing data at 6-month follow-up
Periodo de tiempo: At 6-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 6-month follow-up
|
|
Adverse events at 6-month follow-up
Periodo de tiempo: At 6-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 6-month follow-up
|
|
Adverse events at 1-week follow-up
Periodo de tiempo: At 1-week follow-up
|
Participants will report any unfavorable and unintended events
|
At 1-week follow-up
|
|
Adverse events at 1-month follow-up
Periodo de tiempo: At 1-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 1-month follow-up
|
|
Adverse events at 3-month follow-up
Periodo de tiempo: At 3-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 3-month follow-up
|
|
Self-reported abstinence at 1-week follow-up
Periodo de tiempo: At 1-week follow-up
|
Participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 1-week follow-up
|
|
Self-reported abstinence at 1-month follow-up
Periodo de tiempo: At 1-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 1-month follow-up
|
|
Self-reported abstinence at 3-month follow-up
Periodo de tiempo: At 3-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 3-month follow-up
|
|
Self-efficacy at 1-week follow-up
Periodo de tiempo: at 1-week follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 1-week follow-up
|
|
Self-efficacy at 1-month follow-up
Periodo de tiempo: at 1-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 1-month follow-up
|
|
Self-efficacy at 3-month follow-up
Periodo de tiempo: at 3-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 3-month follow-up
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Katherine Lam, PhD, The Hong Kong Polytechnic University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de julio de 2022
Finalización primaria (Anticipado)
31 de diciembre de 2023
Finalización del estudio (Anticipado)
31 de diciembre de 2023
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2021
Primero enviado que cumplió con los criterios de control de calidad
22 de marzo de 2022
Publicado por primera vez (Actual)
28 de marzo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
22 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SDTM-adult
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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 Mixed and match Intervention
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