跳至主要内容
临床试验/NCT03922360
NCT03922360已完成不适用

Smartphone-based Financial Incentives

University of Vermont2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Late Pregnancy Quit Rate

研究概览

简要总结

Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse fetal and infant health problems, and later-in-life chronic conditions among exposed offspring. The most effective intervention for reducing smoking during pregnancy is financial incentives whereby participants earn incentives (e.g., gift cards, cash) contingent on objective evidence of smoking abstinence. However, financial incentives-based interventions are typically delivered in relatively intense protocols requiring frequent clinic visits, which limits the geographical range over which services can be delivered and potentially denies treatment to those residing in remote or otherwise difficult to reach settings.

The present study will examine the feasibility, efficacy, and cost-effectiveness of a smartphone-based financial incentives intervention whereby smoking monitoring and delivery of incentives are completed remotely using a mobile app (to be designed by DynamiCare Health, Inc.). Eligible participants who complete the informed consent process will be randomized to one of two conditions: an incentives condition wherein women will receive financial incentives contingent on the remote submission of breath and saliva specimens indicating abstinence from recent smoking (described below), or a best practices control condition in which women will receive usual care for smoking cessation that is provided at their obstetrical clinics, as well as three brief educational sessions and referral to the Vermont (or other state) pregnancy-specific quit line by our research staff.

For inclusion in the study, women must meet the following criteria: (a) > 18 years of age, (b) report being smokers at the time they learned of the current pregnancy, (c) report smoking in the 7 days prior to completing their phone eligibility screening, (c) < 25 weeks pregnant, (d) speak English, (e) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 [2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported owning a smartphone). Exclusion criteria include: (a) current or prior mental or medical condition that may interfere with study participation (assessed via self-report during phone eligibility screening), (b) smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), and (d) self-report currently being maintained on opioid maintenance therapy (e.g., methadone, buprenorphine).

Participants randomized to the incentives condition will select a quit date (either the first or second Monday following their enrollment), and will submit videos of themselves blowing into a breath CO monitor twice daily during week 1. They will receive incentives for every sample where expired breath CO is < 6 ppm. Beginning in week 2 and extending through week 6, participants will submit videos twice per week (Monday/Thursday) for which they will receive incentives for providing videos of themselves completing saliva cotinine tests indicating smoking abstinence. From week 7 until delivery, participants will submit videos once per week and will continue to receive incentives for saliva cotinine tests indicating no smoking. During the postpartum period, women will submit videos twice weekly for the first 4 weeks and once weekly from weeks 5-12. Women will receiving incentives for negative breath and saliva samples, and the value of incentives will increase with each consecutive sample indicating smoking abstinence. Participants will not receive incentives for missed samples or samples that indicate smoking, and the incentive schedule will be reset at its starting value. However two consecutive negative samples following a missed or positive sample will restore the incentive to its prior value.

Women in both conditions will complete seven formal assessments of their smoking status during their participation along with a treatment acceptability questionnaire and semi-structured interview on barriers and facilitators of treatment engagement.

We conducted a power analysis to estimate the number of participants required to detect treatment effects assuming late-pregnancy abstinence rates of approximately 40% vs. < 10% (incentives vs. best practices, respectively), and 24-week postpartum abstinence rates of approximately 20% vs. < 5%. The proposed sample size of 76 per treatment condition will result in at least 80% power to detect a difference between the two treatment conditions in abstinence rates of 40% vs. 10 % at late-pregnancy or 20% vs. 5% at 24-weeks postpartum assessments using a chi-square test and significance level of 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • > 18 years of age
  • report being smokers at the time they learned of the current pregnancy
  • report smoking in the 7 days prior to completing their preliminary eligibility screening,
  • < 25 weeks pregnant
  • speak English
  • own a smartphone

排除标准

  • current or prior mental or medical condition that may interfere with study participation (assessed via self-report during formal intake assessment completed online or by phone using a medical and psychosocial history questionnaire)
  • smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
  • exposed to unavoidable occupational sources of CO (e.g., car mechanic)
  • report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine).

研究组 & 干预措施

Best Practices

Active Comparator

干预措施: Best Practices (Behavioral)

Best Practices + Financial Incentives

Experimental

干预措施: Smartphone-based Financial Incentives (Behavioral)

结局指标

主要结局

Late Pregnancy Quit Rate

时间窗: 28 weeks gestation or later

Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

4-week Postpartum Quit Rate

时间窗: 4 weeks following the date that participants deliver their infant

Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

Longest Duration of Abstinence (LDA)

时间窗: LDA will be measured from participant's date of enrollment in the study to 24-wks postpartum

Consecutive days of no smoking using biochemical verification (cotinine-negative saliva at the formal assessments described above) plus self-report (cigarettes per day from enrollment to 24 wks postpartum reported during timeline follow-back conducted over the phone)

12-week Postpartum Quit Rate

时间窗: 12 weeks following the date that participants deliver their infant

Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

Gestational age at delivery

时间窗: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates

Gestational age (in weeks) at delivery as reported on delivery reports among infants born to mothers enrolled in the study

Early Pregnancy Quit Rate

时间窗: One month after participant's enrollment date

Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

8-week Postpartum Quit Rate

时间窗: 8 weeks following the date that participants deliver their infant

Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

24-week Postpartum Follow-up

时间窗: 24 weeks following the date that participants deliver their infant

Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

Mean birth weight

时间窗: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates

Mean birth weight (in grams) as reported on delivery reports among infants born to mothers enrolled in the study

NICU admissions

时间窗: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates

Yes/no regarding whether infant was admitted to the NICU, and number of days in the NICU, as reported on delivery reports among infants born to mothers enrolled in the study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison N Kurti

Research Assistant Professor

University of Vermont

研究点 (2)

Loading locations...

相似试验