- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03272113
SKIP-IT Smoking Cessation in Pregnancy (SKIP-IT)
Promoting Smoking Cessation During Pregnancy: a Combined Feasibility and Pilot Trial of a Theory-based Intervention Using Narrative, Images and Embedded Behaviour Change Techniques, Delivered Via Text-messaging
연구 개요
상세 설명
Smoking during pregnancy carries serious risks to mother and infant health. More babies whose mothers smoke are stillborn or die within the first year of life. Smoking during pregnancy results in increased rates of intrauterine growth retardation, preterm birth, and babies' longer-term risk of developing heart disease and diabetes. Pregnant women who smoke are more likely to experience miscarriage, placental abruption, pregnancy-induced hypertension and later conditions such as lung cancer and heart disease.
Reduction in smoking in pregnancy has been a long standing health policy target however there is limited evidence of effectiveness of many smoking cessation interventions and their uptake is generally low. We have developed, and carried out initial testing of an intervention to support smoking cessation in pregnant women using narrative, story-telling delivered via automated text-messages. The intervention aims to alter women's perceptions of risk, social norms, outcomes and self-efficacy using three key elements. 1. a narrative story of a fictional young pregnant woman 'Megan' trying to stop smoking by overcoming a series of commonplace barriers. 2) images showing the size of their fetus and its stage of development 3) an interactive 'help' function to receive a supportive, tailored response. Behaviour change techniques for smoking cessation in pregnancy are embedded in the intervention.
A randomised controlled trial is required to test the effectiveness of the intervention in reducing smoking in pregnancy. The aim of this study is to investigate the feasibility and likelihood of success of the narrative and image-based intervention for smoking cessation in pregnant women. If successful the intervention will be tested in a full-scale (Phase III) multi centre randomised controlled trial.
Objectives:
- To assess acceptability and willingness to be randomised to the narrative and image based intervention or usual care.
- To assess and compare the feasibility of recruitment strategies, the level of participants' retention in the study and engagement with the intervention.
- To assess the acceptability and likely impact of the intervention among pregnant smokers.
- To estimate the required sample size for a full trial.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ayr, 영국
- NHS Ayrshire and Arran
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Perth, 영국
- NHS Tayside
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women 16 years of age or over,
- Live within the catchment areas of study sites,
- Up to and including 14 weeks of pregnancy,
- Current smoker,
- Own or regularly use a mobile phone with media capability,
- Understand written English,
- Able to give informed consent.
Exclusion Criteria:
- Women who do not currently smoke,
- Live outside the catchment areas of study sites,
- Over 14 weeks of pregnancy,
- Do not use or have access to a mobile phone with media capability,
- Cannot understand written English,
- Not able to give informed consent,
- Already enrolled in an alternative formal smoking cessation trial at the time of referral to the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: Control
Usual care to provided by smoking cessation services in the two study sites. Site one: support from a specialist advisor using motivational interviewing, one to one, group and telephone support. Site two: a smoking cessation incentive scheme administered through community pharmacies. Women who are verified by CO testing to have stopped smoking receive £12.50 per week. |
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실험적: Intervention
Women will receive usual care as described above plus the SKIP-IT intervention
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A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Recruitment rate
기간: 23 months
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Progression to a full trial will require recruitment ≥50% of women who give permission to have their details passed to the research team (i.e.
those who express initial interest in the study).
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23 months
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Drop out rate
기간: 23 months
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Progression to a full trial will require <30% dropout
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23 months
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Direction of effect
기간: 23 months
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Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.
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23 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Engagement
기간: 23 months
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Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.
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23 months
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Acceptability
기간: 23 months
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Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points
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23 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Smoking cessation outcomes
기간: At each subsequent data collection time-point (4 weeks post-randomisation, 36 weeks of pregnancy, 6-7 weeks post due-date, 12-13 weeks post due-date)
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At each subsequent data collection time-point (4 weeks post-randomisation, 36 weeks of pregnancy, 6-7 weeks post due-date, 12-13 weeks post due-date)
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공동 작업자 및 조사자
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
- RMS2119
- HIPS/16/4 (기타 보조금/기금 번호: Scottish Government Chief Scientist Office)
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. .
SKIP-IT에 대한 임상 시험
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University of WashingtonNational Institute of Nursing Research (NINR)완전한
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University of Texas at AustinBaylor College of Medicine; University of Kansas Medical Center완전한
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Integro Theranostics모병
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Shire완전한헌터 증후군스페인, 미국, 캐나다, 영국, 프랑스, 호주, 멕시코
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Oslo University HospitalCentre for Appearance Research, University of the West of England, UK초대로 등록화상 | 구순구개열 | 두개안면 이상 | 피부 상태 | 눈에 보이는 차이로 이어지는 기타 조건노르웨이
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Liverpool School of Tropical MedicineKenya Medical Research Institute; LVCT Health아직 모집하지 않음임신 | 건강 시스템 | 전자 커뮤니티 건강 정보 시스템 | 산전 클리닉 활용
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Massachusetts General HospitalNational Cancer Institute (NCI)완전한