- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01277250
Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
2015년 6월 17일 업데이트: University of Alabama at Birmingham
This project, "Web-based Smoking Cessation Intervention: transition from inpatient to outpatient," addresses smoking among hospitalized patients, whose rates are higher than among the general population.
Hospitalization offers a unique opportunity to intervene, as it requires temporary abstinence and patients are focused on health concerns.
Hypotheses: A tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home will be effective.
Further, the investigators hypothesize that this approach will be cost-effective.
Specific Aims: 1.
To test the effectiveness of a web-based smoking cessation intervention.
2. To determine the cost-effectiveness of this approach.
Research Design - Methods: A randomized two-arm follow-up design will be used to test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Patients randomized to this arm will be contacted by hospital staff, trained as 'transition coaches,' to engage in Decide2Quit, an interactive web-based program that offers personalized and tailored messages, e-group support, and text messages promoting tobacco abstinence.
All hospitalized patients will receive standardized smoking cessation materials.
As well, physicians can order nicotine replacement therapy via the hospital's electronic order system.
The investigators primary outcome is biologically confirmed and self-reported tobacco abstinence at 6 months follow-up; the investigators will also assess self-reported quit rates at 3 and 12 months and variables hypothesized to predict quit success.
We will measure health care utilization and quality of life to allow testing the cost-effectiveness of this program conducted from the perspective of a hospital, health care payers, patients and society.
Significance of results: At study completion the investigators will know whether imbedding smoking cessation into usual hospital care, with minimal hospital-staff burden, and an interactive web-based tailored intervention program is an effective way to reduce smoking rates among hospitalized patients, and if it is cost-effective.
This program will be an "off the shelf approach that could be disseminated easily.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
1548
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
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Alabama
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Birmingham, Alabama, 미국, 35294
- The University of Alabama at Birmingham - Lung Health Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
19년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 19 years of age or older
- Current smoker (at least one puff in the last 30 days)
- Regular (at least weekly) email/internet access
- Can read and speak English
- Can communicate well enough to provide meaningful responses to the screening questions and informed consent
- Well enough to participate (provide meaningful responses to the screening questions and informed consent)
- On standard or contact isolation only
- Cognitively able to participate (to provide meaningful responses to the screening questions and informed consent)
- Does not have another household member participating in this study
Exclusion Criteria:
- Under age 19
- Non-smoker
- Cannot read and speak English
- No email/internet access
- Cannot communicate well enough to provide meaningful responses to the screening questions and informed consent
- Too ill to participate (provide meaningful responses to the screening questions and informed consent)
- On isolation precautions other than standard or contact
- Cognitively unable to participate (to provide meaningful responses to the screening questions and informed consent)
- Has another household member participating in this study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Usual Care
Standard smoking cessation information provided to all hospitalized patients as part of discharge packet.
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Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital.
Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
다른 이름들:
|
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실험적: Smoking Cessation Program
Web-based program tailored to patients who smoke and are hospitalized.
Program is tailored to participant's specific hospital experience and other characteristics.
E-messages, social support and a "transition coach" are provided to each participant in this condition.
|
Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital.
Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Smoking abstinence
기간: 6 months
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Biochemically-verified (cotinine) and self-reported tobacco abstinence
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Smoking abstinence
기간: 3 and 12 months
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self-reported tobacco abstinence
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3 and 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kathleen F Harrington, PhD, MPH, The University of Alabama at Birmingham
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 7월 1일
기본 완료 (실제)
2014년 9월 1일
연구 완료 (실제)
2014년 11월 1일
연구 등록 날짜
최초 제출
2011년 1월 12일
QC 기준을 충족하는 최초 제출
2011년 1월 13일
처음 게시됨 (추정)
2011년 1월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 6월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 6월 17일
마지막으로 확인됨
2015년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1U01DA031515 (미국 NIH 보조금/계약)
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. .