- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02613689
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco
연구 개요
상세 설명
Participants will be randomized to either the Scheduled Gradual Reduction (SGR) group or the control group. All participants in both groups will complete surveys at the baseline, end of program, and 6 month time points. All participants in both groups will also receive supportive counseling text messages at various times during the day over a period of 4 weeks.
Participants assigned to the SGR intervention group will receive their intervention, in addition to the supportive counseling messages received by the control group, via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University School of Nursing
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Over 18 years of age
- Have used smokeless tobacco for the last year, currently (past 30 days) uses smokeless tobacco daily, and use of at least one or more tins/cans per week
- Have an address in a rural census tract defined by a RUCA code of 4-10.
- Interested in participating in a cessation program
- Have access to a cell phone with unlimited texting ability and have knowledge of text messaging
Exclusion Criteria:
- Non-English speaking
- Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user)
- Currently participating in a smokeless tobacco cessation study
- Family member participating in a smokeless tobacco cessation study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Scheduled Gradual Reduction (SGR)
Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
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Participants in this group will group will receive the Scheduled Gradual Reduction (SGR) smokeless tobacco cessation reduction intervention via text message over a period of four weeks.
Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.
In addition, this group will also receive the support messages that are sent to the control group.
Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
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활성 비교기: Control Group
Subjects will receive SMS support text messages
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Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Proportion of Return Text Messages sent in Response to SGR Intervention
기간: 1 month
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Assessed via text history
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1 month
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Proportion of Support Messages Read by Participants
기간: 1 month
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Self-report
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1 month
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Ratings of Usefulness of the Intervention Received
기간: 1 month
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Ratings will be assessed via patient questionnaire.
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1 month
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Quit Rate at 1 month
기간: 1 month
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Quit rate will be assessed by participant self report via questionnaires.
Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
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1 month
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Quit Rate at 6 Months
기간: 6 months
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Quit rate will be assessed by participant self report via questionnaires.
Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
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6 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Devon Noonan, PhD, Duke University School of Nursing
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 (추정)
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
- Pro00063791
- 1R15CA198841-01 (미국 NIH 보조금/계약)
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