- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07857681
Text Message and Mail Delivery of Tailored Educational Materials to Improve Access to Resources for Smoking Cessation of Menthol Tobacco Cigarettes
An Exploratory Investigation on Effectiveness of Tailored New York State Quitline Services for Cessation of Menthol Tobacco Cigarettes
This clinical trial compares the impact of receiving educational materials containing relevant content about risks from smoking menthol cigarettes which include links to the New York (NY) Smoke-Free website by text message or mail in people who smoke menthol cigarettes. The NY Smoke-Free website includes tailored content developed specifically for menthol smokers and provides resources designed to resonate with the experiences of menthol smokers and address the unique challenges they face in quitting. Delivering tailored educational materials by text message or mail may increase interaction with information about menthol cigarettes and smoking cessation resources compared to those who do not receive the educational messaging.
연구 개요
상태
정황
상세 설명
PRIMARY OBJECTIVES:
I. Assess participant interaction with an educational message about menthol cigarettes by tracking visits to the Quitline website.
II. Assess participant interaction with the educational message delivered by text message with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web site.
III. Assess participant interaction with the educational message delivery by mail with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and quick response (QR) code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
GROUP II: Participants receive standard Quitline materials in the mail on study.
GROUP III: Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New York
-
Buffalo, New York, 미국, 14263
- Roswell Park Cancer Institute
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 18 years or older
- Residents of New York State
- English Speaking
- Willingness to receive and engage with mailed educational materials
- Participants with ability to receive text messaging access to smart device
Exclusion Criteria:
- Report currently smoking menthol cigarettes
- People who do not report currently smoking menthol cigarettes
- Individuals under 18 years of age
- Persons in correctional facilities
- Non-English speaking
- Participants who cannot receive text messaging or have access to smart device
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Cohort II (standard Quitline materials)
Participants receive standard Quitline materials in the mail on study. |
Receive standard Quitline materials
다른 이름들:
|
|
실험적: Group I (educational material by mail)
Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
다른 이름들:
Receive an educational flyer by mail
다른 이름들:
Receive access to a website Receive access to a QR code
다른 이름들:
|
|
실험적: Group III (educational messaging by text)
Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
다른 이름들:
Receive access to a website Receive access to a QR code
다른 이름들:
Receive an educational message by text
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Engagement with quick response (QR) code scans
기간: Up to 12 months
|
QR code will be scanned will be tracked through unique uniform resource locator assigned. Each scan will be documented, allowing for the counting of interactions (Poisson) directly affiliated with the materials distributed. Also, binary (yes/no) (Did the participant interact at least once). Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website Utilization
기간: Up to 12 months
|
total number of visits, unique visitors, |
Up to 12 months
|
|
Interactions with online resources
기간: Up to 12 months
|
Interactions with online resources will include the number of clicks on website, and time spent on various pages. Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website utilization
기간: Up to 12 months
|
Duration of sessions |
Up to 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of website interactions from the mailed flyer
기간: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the mailed flyer
기간: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of website interactions from the text message
기간: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the text message
기간: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Duration spent on the cessation website
기간: Up to 12 months
|
Will assess depth of engagement. |
Up to 12 months
|
|
Number of pages or resources accessed on the website
기간: Up to 12 months
|
Will evaluate participant utilization of the content. |
Up to 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sarah Pearson-Collins, Roswell Park Cancer Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- I-4464925
- NCI-2025-03221 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- I-4464925 (기타 식별자: Roswell Park Cancer Institute)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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