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Phone-Based Postpartum Continuing Care for Smoking Cessation (PPCC)

13 lutego 2018 zaktualizowane przez: Victoria H. Coleman-Cowger, Battelle Memorial Institute

Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy

Smoking is a leading cause of death and other negative health outcomes. While a high percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months postpartum. We propose developing and pilot testing a phone-based postpartum continuing care (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation, reduce relapse, increase early re-intervention, and reduce infant exposure to environmental tobacco smoke in the postpartum period.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

130

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Illinois
      • Bloomington, Illinois, Stany Zjednoczone, 61701
        • Chestnut Global Partners
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21201
        • Maryland Women's Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Eksperymentalny: Standard care plus PPCC
Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum
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.
Inne nazwy:
  • PPCC

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Tobacco Products Per Day
Ramy czasowe: 6 months postpartum
Self-reported number of tobacco products smoked per day
6 months postpartum

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Tobacco Products Per Day
Ramy czasowe: 3 months postpartum
Self-reported number of tobacco products smoked per day
3 months postpartum
Past 90-day Tobacco Use
Ramy czasowe: 3 months postpartum
Self-reported number of days smoked in past 90 days
3 months postpartum
Past 90-day Tobacco Use
Ramy czasowe: 6 months postpartum
Self-reported number of days smoked tobacco in past 90 days.
6 months postpartum
Times Mother Smoked While Breastfeeding
Ramy czasowe: Baby's birth to 6 months postpartum
Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.
Baby's birth to 6 months postpartum
Times Mother Smoked in the Room With Infant
Ramy czasowe: Baby's birth to 6 months postpartum
Based on the number of days of smoking in the same room with infant in the past 90.
Baby's birth to 6 months postpartum
NicCheck Test Results for Cotinine Level From Infant Urine
Ramy czasowe: 6 months postpartum
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.
6 months postpartum

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Victoria H Coleman-Cowger, PhD, Battelle Memorial Institute
  • Dyrektor Studium: Katrina Mark, MD, University of Maryland School of Medicine

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2012

Zakończenie podstawowe (Rzeczywisty)

1 marca 2015

Ukończenie studiów (Rzeczywisty)

1 marca 2015

Daty rejestracji na studia

Pierwszy przesłany

11 września 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 września 2012

Pierwszy wysłany (Oszacować)

13 września 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 marca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 lutego 2018

Ostatnia weryfikacja

1 lutego 2018

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 1R34DA032683-01A1 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Researchers may request de-identified aggregate data in 2017 via email from the PI of record by submitting a formal request with desired variables.

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Standard care

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