Smoking Cessation After Hospitalization for a Cardiopulmonary Illness (STOPP)
17. mai 2017 oppdatert av: Faysal M. Hasan, MD, North Shore Medical Center
Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients
Smoking-related cardiopulmonary diseases account for a large number of hospital admissions.
We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge.
We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own.
We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group.
All patients received self-help brochures and in-hospital counseling.
Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge.
They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge.
7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.
Studietype
Intervensjonell
Registrering (Faktiske)
164
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Massachusetts
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Salem, Massachusetts, Forente stater, 01970
- North Shore Medical Center
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Hospitalized patients with a Cardiopulmonary admission.
Exclusion Criteria:
- Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Hypnotherapy
Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session.
They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
|
One 90 minute session within 2 weeks of hospital discharge
Andre navn:
|
|
Eksperimentell: Nicotine Replacement Therapy
Patients recieved a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays.
Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
|
free one month supply after hospital discharge
Andre navn:
|
|
Eksperimentell: Hypnotherapy and Nicotine replacement
The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.
|
One 90 minute session within 2 weeks of hospital discharge
Andre navn:
free one month supply after hospital discharge
Andre navn:
|
|
Ingen inngripen: Self-Quit group
Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Abstinence From Smoking
Tidsramme: at 26 weeks after hospitalization
|
Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness.
Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy.
Patients lost to follow up were considered to be persistent smokers.
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at 26 weeks after hospitalization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Smoking Cessation
Tidsramme: at 12 weeks after hospitalization
|
Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test.
This included participants in groups receiving hypnotherapy, NRT or both.
Self quit group was not approached until 26 weeks after discharge.
Patients lost to follow up were considered smokers.
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at 12 weeks after hospitalization
|
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Smoking Abstinence Rate at 12 and 26 Weeks
Tidsramme: 12 weeks and 26 weeks after hospital discharge
|
Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.
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12 weeks and 26 weeks after hospital discharge
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Faysal Hasan, M.D., North Shore Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2006
Primær fullføring (Faktiske)
1. mai 2009
Studiet fullført (Faktiske)
1. mai 2009
Datoer for studieregistrering
Først innsendt
12. februar 2013
Først innsendt som oppfylte QC-kriteriene
13. februar 2013
Først lagt ut (Anslag)
15. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STOPP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
published in: Complementary Therapies in Medicine 2014: 22: 1-8.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .