- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02123329
Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Doha, 카타르
- Primary Health Corporation (PHC) pharmacies
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Doha, 카타르
- Qatar Petroleum pharmacies
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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).
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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).
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실험적: 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.
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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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Self-reported 7-day Point Prevalence Abstinence
기간: 3 months
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Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
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3 months
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Self-reported 30 Day Smoking Abstinence
기간: 3 months
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Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
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3 months
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Self-reported Continuous Abstinence at 3 Months
기간: 3 months
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Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
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3 months
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Self-reported 7-day Point Prevalence Abstinence
기간: 6 months
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Defined as having smoked no cigarettes for the previous 7 days
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6 months
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Self-reported 30-day Point Prevalence Abstinence
기간: 6 months
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Defined as having smoked no cigarettes in the last 30 days
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6 months
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Self-reported Continuous Abstinence
기간: 6 months
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Defined as having smoked no cigarettes since quit day
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6 months
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Self-reported 7-day Point Prevalence Abstinence
기간: 12 months
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Defined as having smoked no cigarettes for the previous 7 days
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12 months
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Self-reported 30-day Point Prevalence Abstinence
기간: 12 months
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Defined as having smoked no cigarettes in the last 30 days
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12 months
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Self-reported Continuous Abstinence
기간: 12 months
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Defined as having smoked no cigarettes since quit day at 12 months
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12 months
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Objective Smoking Abstinence
기간: 12 months
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Smoking abstinence as objectively verified by the CO exhaled test at 12 months
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Health Related Quality of Life
기간: 6 month
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Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
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6 month
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Maguy S El Hajj, PharmD, Qatar University
간행물 및 유용한 링크
일반 간행물
- El Hajj MS, Kheir N, Al Mulla AM, Shami R, Fanous N, Mahfoud ZR. Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial. BMC Public Health. 2017 Feb 20;17(1):215. doi: 10.1186/s12889-017-4103-4.
- El Hajj MS, Kheir N, Al Mulla AM, Al-Badriyeh D, Al Kaddour A, Mahfoud ZR, Salehi M, Fanous N. Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial. Trials. 2015 Feb 26;16:65. doi: 10.1186/s13063-015-0570-z.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Control arm (i.e: regular care)에 대한 임상 시험
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University of AlbertaUniversity Hospital Foundation완전한
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Rabin Medical Center종료됨
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George Washington UniversityNew York University; The Miriam Hospital완전한