- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01684592
Phone-Based Postpartum Continuing Care for Smoking Cessation (PPCC)
Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The large majority of women who quit smoking during pregnancy relapse in the first six months postpartum, highlighting a need for effective postpartum continuing care that supports women through the challenging postpartum period when stress is high and motivation to stay quit may decline. Existing relapse prevention interventions (typically delivered during pregnancy) have been found to be of little benefit during the postpartum period, suggesting the need for a more formal continuing care approach. Phone-based protocols for smoking cessation have been widely disseminated and effective because they address the need for flexible access, but are passive and not typically utilized by women in the postpartum period.
The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care (PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery Management Checkups (RMC)-- shown to be effective with other populations. The experimental PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women are more likely to relapse, and provide education and monitoring of the infant's direct and indirect exposure to nicotine through breastfeeding and secondhand smoke. We will evaluate PPCC's effectiveness relative to a passive referral to a 24/7 hotline, which is current standard care.
Approximately one hundred thirty women in their first or second trimester of pregnancy who were nicotine-dependent in the past year, currently smoke, or quit within the past 90 days will be recruited at their first prenatal appointment at the Maryland Women's Center (MWC) in Baltimore, Maryland. All women will receive the clinic's standard of care for smoking cessation--the 5 A's --during pregnancy from their physician. Half will be randomly assigned to an experimental group getting PPCC for 6 months postpartum and half to a control group receiving only a referral to a passive 24/7 state quit line postpartum. It is expected that in the 6 months following childbirth women in the experimental PPCC (relative to those in the control group) will: a) smoke fewer cigarettes, b) smoke fewer days, c) go longer before postpartum relapse, d) have less time between relapse and talking to a health professional about smoking, e) have less time between relapse and resumption of abstinence , f) smoke fewer times while breastfeeding, g) smoke fewer times while in the same room as the infant, and h) reduce their infant's cotinine levels.
The aims of this pilot project are to develop PPCC from existing evidence-based approaches, demonstrate the feasibility of implementing the PPCC intervention with at least 80% compliance and at least 80% follow-up at each wave, and evaluate the effect size associated with receiving standard care vs. standard care + PPCC in order to understand the promise of and appropriate power required for a larger clinical trial.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Bloomington, Illinois, Estados Unidos, 61701
- Chestnut Global Partners
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Maryland Women's Center
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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:
- first or second trimester of pregnancy
- age 18 or older
- self-reported tobacco use in the past 90 days or nicotine-dependence in the past year
Exclusion Criteria:
- intend to terminate their pregnancy
- intend to move out of the city within the next 12 months
- are unable to provide informed consent and participate in English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Standard care
Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)
|
All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy.
The 5 A's brief intervention was modified by American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking.
It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.
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Experimental: Standard care plus PPCC
Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum
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All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy.
The 5 A's brief intervention was modified by American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking.
It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.
PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum.
The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence.
Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Tobacco Products Per Day
Periodo de tiempo: 6 months postpartum
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Self-reported number of tobacco products smoked per day
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6 months postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Tobacco Products Per Day
Periodo de tiempo: 3 months postpartum
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Self-reported number of tobacco products smoked per day
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3 months postpartum
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Past 90-day Tobacco Use
Periodo de tiempo: 3 months postpartum
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Self-reported number of days smoked in past 90 days
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3 months postpartum
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Past 90-day Tobacco Use
Periodo de tiempo: 6 months postpartum
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Self-reported number of days smoked tobacco in past 90 days.
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6 months postpartum
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Times Mother Smoked While Breastfeeding
Periodo de tiempo: Baby's birth to 6 months postpartum
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Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.
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Baby's birth to 6 months postpartum
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Times Mother Smoked in the Room With Infant
Periodo de tiempo: Baby's birth to 6 months postpartum
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Based on the number of days of smoking in the same room with infant in the past 90.
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Baby's birth to 6 months postpartum
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NicCheck Test Results for Cotinine Level From Infant Urine
Periodo de tiempo: 6 months postpartum
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Infant urine was collected at 6 months postpartum using the "cotton roll" method of urine collection.
Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction.
The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine.
Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer.
The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between "low" (score 1-6) versus "high" (score 7-14) nicotine consumption.
Absence of a color is considered a negative result (score 0).
Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.
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6 months postpartum
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Victoria H Coleman-Cowger, PhD, Battelle Memorial Institute
- Director de estudio: Katrina Mark, MD, University of Maryland School of Medicine
Publicaciones y enlaces útiles
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
- 1R34DA032683-01A1 (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
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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