- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01331226
Support Person Intervention to Promote a Smoking Helpline (ClearWay #4)
Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
연구 개요
상태
정황
상세 설명
We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a "real-world" setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
The support person must
- reside in Minnesota
- be 18 years of age or older
- provide written informed consent
- be a never or former cigarette smoker (no cigarette smoking in the past 6 months)
- want to support a current cigarette smoker (has smoked a total of >1 cigarettes during the past 7 days) who is 18 years of age or older, resides in Minnesota, and has not been enrolled in a helpline or any other cessation program in the last 3 months
- be able and willing to participate in all aspects of the study
- have access to a working telephone
- have current and anticipated contact (any combination of face-to-face, telephone, text messaging, or electronic mail) with the smoker on at least 3 days a week for the 30 week study duration.
Exclusion Criteria:
- Support persons will be excluded if another support person from the same household has enrolled.
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: 3 session telephone counseling
|
3 sessions of telephone counseling
|
|
실험적: 1 session telephone counseling
|
1 session of telephone counseling
|
|
활성 비교기: written materials
|
written materials only
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
helpline utilization
기간: At 7 month follow-up
|
smoker calls to the helpline
|
At 7 month follow-up
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
smoker quit attempts and cessation
기간: 7 month follow-up
|
7 month follow-up
|
공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 11-001796
- 10-008318 (기타 식별자: Mayo Clinic)
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