Feasibility, Acceptability, and Preliminary Outcomes of a Smartphone-Based Program for Reduction in Alcohol Consumption
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Proportion of participants who complete all 12 weekly follow-up assessments
研究概览
简要总结
Prospective, open label, single center clinical study enrolling up to 100 adult participants to evaluate the feasibility, acceptability, and preliminary outcomes of the Pivot Clear smartphone-based alcohol reduction program.
详细描述
This is a prospective, open label, single center clinical study conducted with institutional review board (IRB) approval enrolling up to 100 adult participants who report at-risk alcohol consumption behavior and would like to reduce or eliminate alcohol consumption. The study will be performed remotely on an ambulatory basis. Participants will be asked to set up and use the Pivot Clear program. The program includes an app, personal breathalyzer, and short message service (SMS) text-based coaching with an alcohol reduction specialist. The study duration is 52 weeks. While participants will have access to the program for 52 weeks, it is expected that for most participants, most active participation in the program will be complete by 12 weeks. The primary reporting time point will be 12 weeks, with expected passive, longer-term follow-up outcomes collected at 26 weeks and 52 weeks. Participants will receive online questionnaires at intervals throughout the study (baseline, weekly for the first 12 weeks, at 26 weeks and at 52 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score of ≥ 3 for women and ≥ 4 for men on the AUDIT-C at screening
- •Would like to reduce or eliminate alcohol consumption
- •Resident of the United States
- •Able to read and comprehend English
- •Owns and uses a smartphone compatible with the study app (iPhone 6 and above, operating system iOS (iPhone operating system) 15 and above, or Android 7.0 and above, operating system Android 7.0 and above)
- •Has daily internet access on smartphone
- •Comfortable downloading and using smartphone apps
- •Interested in working with an alcohol reduction coach via SMS text
- •Willing to sign the Informed Consent Form (ICF)
排除标准
- •Currently using other support to reduce or quit alcohol, including apps, coaching, support groups, classes or quit programs
- •Pregnant (self-reported)
- •Self-reported past or present diagnosis of Alcohol Use Disorder (AUD)
- •Self-reported past or present diagnosis of Substance Use Disorder
- •Current use of the following medications: suboxone, methadone, or daily use of a benzodiazepine [including Alprazolam (e.g., Xanax), lorazepam (e.g., Ativan), clonazepam (e.g., Klonopin), diazepam (e.g., Valium), and temazepam (e.g., Restoril)]
- •History of hospitalization or in-patient treatment due to alcohol use
- •Using other alcohol reduction or abstinence apps, coaching, support groups, classes, or programs at study entry
- •Failure to provide contact or collateral information, and/or failure to verify email address
- •Participation in a previous study sponsored by Pivot Health Technologies, Inc. (formerly Carrot Inc.)
结局指标
主要结局
Proportion of participants who complete all 12 weekly follow-up assessments
时间窗: 12 weeks
Calculated as the number of participants who complete 12/12 of the weekly follow-up assessments (specifically during the first 12 weeks of the study), divided by the total number of enrolled participants.
次要结局
- Proportion of participants with average drinks per day ≤ 2/day for men and ≤ 1/day for women(1-12, 26, and 52 weeks)
- Proportion of participants who reduced their AUDIT-C score category by by ≥ 1 risk level(12, 26, and 52 weeks)
- Average daily alcohol consumption(1-12, 26, and 52 weeks)
- Readiness to change(4 and 12 weeks)
- Satisfaction with current drinking behavior(12, 26, and 52 weeks)
- Average weekly alcohol consumption(1-12, 26, and 52 weeks)
- Average drinks per drinking day(1-12, 26, and 52 weeks)
- Maximum number of drinks on any day over the timeline follow-back period(1-12, 26, and 52 weeks)
- Proportion of days abstinent(1-12, 26, and 52 weeks)
- User feedback - set up and getting started with the program(4 weeks)
- User satisfaction - whether the program helped the participant maintain alcohol reduction(12, 26, and 52 weeks)
- User feedback - initial reactions to program design, specific program features including the breathalyzer, coaching, lessons, and drink tracking(1 week)
- Trial feasibility - enrollment(Baseline)
- Trial feasibility - questionnaire completion(52 weeks)
- Proportion of participants who reduced their AUDIT score category by by ≥ 1 risk level(12, 26, and 52 weeks)
- Number of heavy drinking days(1-12, 26, and 52 weeks)
- Proportion of participants who complied with the low-risk guideline for problematic drinking(1-12, 26, and 52 weeks)
- Proportion of participants with an AUDIT-C score below the threshold for unhealthy alcohol use in the U.S.(12, 26, and 52 weeks)
- Proportion of participants with an AUDIT score within the "lower risk" category(12, 26, and 52 weeks)
- Drinking motivations(12, 26, and 52 weeks)
- Reasons for desired change in drinking habits(Baseline)
- Expected success to change drinking habits(4 and 12 weeks)
- User satisfaction - Net Promoter Score(4, 12, and 26 weeks)
- Average duration of continuous abstinence(12, 26, and 52 weeks)
- Proportion of participants who reduced their World Health Organization (WHO) risk drinking level by ≥ 1 risk level(12, 26, and 52 weeks)
- Expected difficulty maintaining reduction/abstinence(4 and 12 weeks)
- User satisfaction - how use of the program has affected alcohol consumption(5 weeks)
- User satisfaction - effectiveness of the program(12 weeks)
- Adverse consequence related to alcohol(12, 26, and 52 weeks)
- Desire to change drinking habits(Baseline)
- User satisfaction - program's ability to help someone reduce or quit alcohol(10 weeks)
- User satisfaction - perceived need for the program(4 weeks)
- User satisfaction - effect of program on motivation to reduce/abstain(3 weeks)
- Engagement with program - number of weeks with app openings(26 weeks)
- Engagement with program - average number of messages(26 weeks)
- User feedback - program design, specific program features including the breathalyzer, coaching, lessons, and drink tracking(2, 3, 5, and 12 weeks)
- User feedback - possible future program features(12 weeks)
- Engagement with the program - app openings(26 weeks)
- Change in ratings of self-reported health indicators(12 and 26 weeks)
- Well-being(12, 26, and 52 weeks)
- Use of other alcohol reduction or abstinence tools (apps, counseling, medications, etc.)(11, 26, and 52 weeks)
- Depressive symptoms(12, 26, and 52 weeks)
- Resilience(12, 26, and 52 weeks)
- User satisfaction - aspects of program participant enjoyed most/least(12 weeks)
- Engagement with program - number of days with app openings(26 weeks)
- Engagement with program - average duration of app sessions(26 weeks)
- Engagement with program - use of app features(26 weeks)
- Engagement with program - average number of weeks with coach engagement(26 weeks)
- Average rating of positive change experienced in self-reported health indicators(12 and 26 weeks)
- Anxiety(12, 26, and 52 weeks)
研究者
Jennifer Marler, MD
VP of Clinical and Medical Affairs
Pivot Health Technologies Inc.