Smoking Cessation After Hospitalization for a Cardiopulmonary Illness (STOPP)
17 maj 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
164
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Massachusetts
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Salem, Massachusetts, Förenta staterna, 01970
- North Shore Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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One 90 minute session within 2 weeks of hospital discharge
Andra namn:
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Experimentell: 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.
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free one month supply after hospital discharge
Andra namn:
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Experimentell: 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.
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One 90 minute session within 2 weeks of hospital discharge
Andra namn:
free one month supply after hospital discharge
Andra namn:
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Inget ingripande: Self-Quit group
Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Abstinence From Smoking
Tidsram: at 26 weeks after hospitalization
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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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Smoking Cessation
Tidsram: at 12 weeks after hospitalization
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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
Tidsram: 12 weeks and 26 weeks after hospital discharge
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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
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Faysal Hasan, M.D., North Shore Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2006
Primärt slutförande (Faktisk)
1 maj 2009
Avslutad studie (Faktisk)
1 maj 2009
Studieregistreringsdatum
Först inskickad
12 februari 2013
Först inskickad som uppfyllde QC-kriterierna
13 februari 2013
Första postat (Uppskatta)
15 februari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STOPP
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
published in: Complementary Therapies in Medicine 2014: 22: 1-8.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .