- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03538678
Just Kwit: Mobile Intervention for Tobacco Cessation
연구 개요
상세 설명
The investigators will recruit hospitalized young adult smokers aged 18-30 interested in cessation over a six-month period. Patients will all receive a UPMC Tobacco Treatment Service counseling session focused on motivational interviewing prior to participation in the study. Upon consent, participants will then be randomized 1:1 to either standard patient-initiated follow-up or use of the Kwit app. Participants will be stratified by sex because males and females are known to have highly variable responses to existing tobacco control interventions. Investigators will systematically assess feasibility using established Likert-type items factors such as interaction, features, engagement, trust, and impact.
If a participant consents to the study, they will be given a brief survey to collect general information related to their smoking behavior. After 30 days, a follow-up survey will be conducted to assess their current smoking behavior. Participants randomized to the experimental arm will be asked additional questions about their use of the smartphone app.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- UPMC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18-30 smokers interested in cessation (>5 cigarettes/day over the past 30 days)
- Must own an Apple or Android based smartphone.
Exclusion Criteria:
- Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Kwit app
Use of Kwit smartphone app
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Kwit smarphone app
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간섭 없음: Standard of care
Patient initiated follow-up post discharge
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App
기간: 1-month
|
Assessment of feasibility - Descriptive statistics that will be obtained via a follow up survey will be used to assess feasibility. The follow up survey will be administered one month after discharge via email, phone or in-person, determined by the preference of the participant. Specific questions will be asked asking participants to rate the Kwit smartphone application based on helpfulness, ease of use, and to list frustrations and helpful aspects of the application. How helpful was the Kwit app? Very helpful Somewhat helpful Neutral Not very helpful Not at all helpful Was the app easy to use? Very Somewhat Neutral Not much Not at all Was it frustrating to use? Very Somewhat Neutral Not much Not at all What, if anything, was helpful about the app? What, if anything, was not helpful about the app? |
1-month
|
Feasibility - Frequency of Use
기간: 1-month
|
Assessment of feasibility - Descriptive statistics that will be obtained via a follow up survey will be used to assess feasibility.
The follow up survey will be administered one month after discharge via email, phone or in-person, determined by the preference of the participant.
Specific questions will be asked asking participants to rate the Kwit smartphone application based on frequency of use.
|
1-month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Cessation--point Prevalence Abstinence
기간: 1-month
|
Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation. Since you left the hospital in (month/year), have you smoked a cigarette (even a puff)? In the past 30 days, have you smoked a cigarette, even a puff? In the past 7 days, have you smoked a cigarette, even a puff? |
1-month
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Cessation--cigarettes Smoked
기간: 1-month
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Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation. (On the days you smoked), how many cigarettes on average did you smoke (even a puff)? |
1-month
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Cessation--days Smoked
기간: 1-month
|
Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation. In the past 30 days, on how many days did you smoke (even a puff)? |
1-month
|
Cessation--confidence
기간: 1-month
|
Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation. How confident are you that you will be able to stay quit? |
1-month
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PRO18010454
- K07CA222338 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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