- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02123329
Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Doha, Katar
- Primary Health Corporation (PHC) pharmacies
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Doha, Katar
- Qatar Petroleum pharmacies
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Eligible participants are:
- patients aged 18 years and older who currently smoke one or more cigarettes daily for 7 days, are motivated to quit i.e.: in the preparation stage of the stage-of-change model, able to communicate in Arabic or English and are willing and capable of attending the scheduled sessions at the study pharmacies.
Exclusion criteria are:
- use of other nicotine or tobacco products
- current use or use in the last 30 days of quit smoking aids or medications
- plan to leave Qatar in the next 12 months
- presence of any major medical condition that would prevent use of the nicotine replacement therapy including hypersensitivity to the products, history of or recent myocardial infarction, life-threatening arrhythmias, severe or worsening angina, uncontrolled hypertension and temporomandibular joint disease (in case of nicotine gum)
- pregnancy
- psychiatric illness or other debilitating condition that would interfere with participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Control arm
Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist.
In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
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Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist.
In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
|
Experimental: Intervention arm
Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy.
The sessions will be set at a date and time that is convenient for both the pharmacist and the participant.
The pharmacist will deliver the program at a time different from his or her pharmacy duty regular time.
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The first session will be time-intensive taking around 30 minutes. In this session, the study pharmacist will facilitate the participant's preparation to quit. The participant will select a quit date within the next 2-4 weeks. The pharmacist will discuss with the participant the benefits of smoking cessation and will provide him or her with tailored behavioral and lifestyle strategies. To prevent nicotine withdrawal symptoms, the participant will be offered nicotine replacement therapy (NRT) The first follow-up session will be scheduled after 1 week of the participant's quit day and will take around 20 minutes. In this session, the pharmacist will determine the participant's smoking status and assess the NRT tolerability. • If the participant fails to quit smoking, the pharmacist will carefully review the participant's experience during the attempt to quit and will work through the identified problems
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Self-reported 7-day Point Prevalence Abstinence
Periodo de tiempo: 3 months
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Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
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3 months
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Self-reported 30 Day Smoking Abstinence
Periodo de tiempo: 3 months
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Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
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3 months
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Self-reported Continuous Abstinence at 3 Months
Periodo de tiempo: 3 months
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Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
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3 months
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Self-reported 7-day Point Prevalence Abstinence
Periodo de tiempo: 6 months
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Defined as having smoked no cigarettes for the previous 7 days
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6 months
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Self-reported 30-day Point Prevalence Abstinence
Periodo de tiempo: 6 months
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Defined as having smoked no cigarettes in the last 30 days
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6 months
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Self-reported Continuous Abstinence
Periodo de tiempo: 6 months
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Defined as having smoked no cigarettes since quit day
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6 months
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Self-reported 7-day Point Prevalence Abstinence
Periodo de tiempo: 12 months
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Defined as having smoked no cigarettes for the previous 7 days
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12 months
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Self-reported 30-day Point Prevalence Abstinence
Periodo de tiempo: 12 months
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Defined as having smoked no cigarettes in the last 30 days
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12 months
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Self-reported Continuous Abstinence
Periodo de tiempo: 12 months
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Defined as having smoked no cigarettes since quit day at 12 months
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12 months
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Objective Smoking Abstinence
Periodo de tiempo: 12 months
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Smoking abstinence as objectively verified by the CO exhaled test at 12 months
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Health Related Quality of Life
Periodo de tiempo: 6 month
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Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
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6 month
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maguy S El Hajj, PharmD, Qatar University
Publicaciones y enlaces útiles
Publicaciones Generales
- El Hajj MS, Kheir N, Al Mulla AM, Shami R, Fanous N, Mahfoud ZR. Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial. BMC Public Health. 2017 Feb 20;17(1):215. doi: 10.1186/s12889-017-4103-4.
- El Hajj MS, Kheir N, Al Mulla AM, Al-Badriyeh D, Al Kaddour A, Mahfoud ZR, Salehi M, Fanous N. Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial. Trials. 2015 Feb 26;16:65. doi: 10.1186/s13063-015-0570-z.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Palabras clave
Otros números de identificación del estudio
- NPRP 4 - 716 - 3 - 203
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. .
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