Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Accrual efficiency/Pre-treatment visits
研究概览
简要总结
The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Common to all 3 RCTs:
- •Inclusion criteria:
- •age18+ years
- •stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range (1.5 hours) of each study site (per self report)
- •able to read, speak & verbally comprehend English
- •own an iOS or Android smartphone
- •have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)
- •Specific to RCT 1:
- •Inclusion criteria:
- •a) daily cigarette smoker of 5+ cigarettes/day for 6+ months b) moderate or greater motivation to quit smoking (6+ on the Motivation to Stop Smoking Scale) d) agree to refrain from use of other tobacco products and use of non-study cessation treatments while participating in the trial e) Willing to be randomized to attend remote/in-person visits
排除标准
- •Specific to RCT 1:
- •a) use of tobacco/nicotine products other than cigarettes (except blunts, spliffs, cigars, little cigars, cigarillos) for average of 5_ days per week over the past 3 months b) prior allergy/intolerance to NRT patch or lozenge c). pregnant, breastfeeding, or planning to become pregnant in next 4 months d) use of varenicline, NRT (e.g., patch, gum, lozenge), or bupropion in past 7 days for purpose of quitting smoking e) consumption of >28 alcohol-containing drinks per week g) high risk involvement with illicit or nonmedical prescription drugs (NIDA-modified ASSIST=27+) h) suicide attempt with at least some wish to die in past 3 months i) mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days j) unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations k) for participants age 21+: refusal to provide/show a pack of cigarettes for documentation at the intake visit
研究组 & 干预措施
IN-PERSON intake, BUT REMOTE treatment/assessment
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
干预措施: Combination Nicotine Replacement Therapy (patch and lozenge) (Drug)
REMOTE intake BUT IN-PERSON treatment/assessment
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.
干预措施: Combination Nicotine Replacement Therapy (patch and lozenge) (Drug)
REMOTE intake AND REMOTE treatment/assessment
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
干预措施: Combination Nicotine Replacement Therapy (patch and lozenge) (Drug)
IN-PERSON intake AND IN-PERSON treatment/assessment
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.
干预措施: Combination Nicotine Replacement Therapy (patch and lozenge) (Drug)
结局指标
主要结局
Accrual efficiency/Pre-treatment visits
时间窗: ~1 month
Calculated from visit milestones. Of participants who were eligible on the Brief Screen, the percentage who who attend the (Remote vs. In-Person) Intake Visit, a major accrual bottleneck for in-person trials. Although pre-treatment participant loss from Intake to Clinic 1 is typically modest, we will also explore Intake to T/A Visit 1 (first dose of treatment) attrition and overall pre-treatment attrition (from Brief Screen to T/A Visit 1) for each group.
Trial Quality: Retention
时间窗: ~3 months
Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.
Trial Quality: Treatment adherence/utilization (patient-reported)
时间窗: 8 weeks (assessed at T/A Visits 3, 4, and 5)
As in most studies in the smoking cessation clinical trial literature, we will assess self-reported patch and lozenge use since the previous visit and convert the data to percent adherence separately for patches and lozenges. Pharmacotherapy is initiated at T/A Visit 2; therefore treatment adherence is assessed at T/A Visits 3, 4, and 5).
Trial quality: Biospecimen completion rates
时间窗: 3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
The number of visits (out of 5; T/A Visits 1-5) for which the biospecimen (expired-air CO) is obtained by the clinical site.
次要结局
未报告次要终点
研究者
Larry Hawk, Ph.D.
professor
State University of New York at Buffalo