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Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar

1. juni 2017 oppdatert av: Dr. Maguy El Hajj, Qatar University
Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

314

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Qatar
      • Doha, Qatar
        • Primary Health Corporation (PHC) pharmacies
      • Doha, Qatar
        • Qatar Petroleum pharmacies

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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).
Annen: Control arm (i.e: regular care)
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).
Eksperimentell: 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.
Atferdsmessig: Pharmacist delivered smoking cessation program

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

Andre navn:
  • Participants 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-reported 7-day Point Prevalence Abstinence
Tidsramme: 3 months
Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
3 months
Self-reported 30 Day Smoking Abstinence
Tidsramme: 3 months
Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
3 months
Self-reported Continuous Abstinence at 3 Months
Tidsramme: 3 months
Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
3 months
Self-reported 7-day Point Prevalence Abstinence
Tidsramme: 6 months
Defined as having smoked no cigarettes for the previous 7 days
6 months
Self-reported 30-day Point Prevalence Abstinence
Tidsramme: 6 months
Defined as having smoked no cigarettes in the last 30 days
6 months
Self-reported Continuous Abstinence
Tidsramme: 6 months
Defined as having smoked no cigarettes since quit day
6 months
Self-reported 7-day Point Prevalence Abstinence
Tidsramme: 12 months
Defined as having smoked no cigarettes for the previous 7 days
12 months
Self-reported 30-day Point Prevalence Abstinence
Tidsramme: 12 months
Defined as having smoked no cigarettes in the last 30 days
12 months
Self-reported Continuous Abstinence
Tidsramme: 12 months
Defined as having smoked no cigarettes since quit day at 12 months
12 months
Objective Smoking Abstinence
Tidsramme: 12 months
Smoking abstinence as objectively verified by the CO exhaled test at 12 months
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health Related Quality of Life
Tidsramme: 6 month
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
6 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Qatar University

Samarbeidspartnere

Hamad Medical Corporation

Etterforskere

  • Hovedetterforsker: Maguy S El Hajj, PharmD, Qatar University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. februar 2013

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først innsendt

20. april 2014

Først innsendt som oppfylte QC-kriteriene

24. april 2014

Først lagt ut (Anslag)

25. april 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • NPRP 4 - 716 - 3 - 203

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. .

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