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Background <p>Remote trials (i.e., virtual or decentralized trials), in which patients receive some or all treatment and provide study data without the need to travel to a clinic or medical center, have emerged as a promising approach to conducting clinical trials. However, evidence for the hypothesized benefits of remote trials is weak, consisting primarily of anecdotal reports, uncontrolled studies, and expert opinion. The same is true for hypothesized limitations of remote trials such as technological barriers and aspects of trial rigor. A stronger evidence base is needed to evaluate the impact of remote trials.</p> Methods <p>Remote vs. In-Person Study Evaluation (RISE) was developed to examine the benefits and limitations of remote clinical trials and consists of separate randomized controlled trials (RCTs) for 3 different use cases. In RISE RCT 1 (RISE Above Smoking), the focus of this protocol paper, adults who smoke (AWS) cigarettes will be randomized to Remote vs. In-Person Intake Visit (written consent and eligibility screening). Intake-eligible participants will be re-randomized to Remote vs. In-Person Treatment and Assessment Visits. Recruitment will continue until 200 AWS initiate treatment. All participants will receive 8&#xa0;weeks of combination nicotine replacement therapy (NRT; 14 or 21&#xa0;mg transdermal nicotine patch, based on smoking rate, and 2&#xa0;mg nicotine lozenges) and a printed self-help guide, and will be assessed through 3-month follow-up. Primary outcomes include accrual efficiency, retention, treatment utilization/adherence, and biospecimen completion rates. A key secondary clinical outcome (smoking cessation) will also be assessed. Subsequently, RISE RCTs 2 and 3 will employ harmonized timelines and outcomes in smaller (<i>N</i> = 100 participants who initiate treatment in each) single-site evaluations of remote vs. in-person trial components in different contexts: an mHealth intervention for people with depression symptoms and an opioid overdose education and naloxone intervention for people with opioid/stimulant use disorder.</p> Discussion <p>The RISE RCTs will provide novel, rigorous evidence regarding the impact of remote trial methods on trial efficiency and rigor, including the degree to which these effects generalize across clinical contexts and participant characteristics.</p> Trial registration <p>RCT 1 was preregistered on February 12 2025, on ClinicalTrials.gov, NCT06822049. <a href="https://clinicaltrials.gov/study/NCT06822049">https://clinicaltrials.gov/study/NCT06822049</a>. (RCTs 2 and 3 will be registered prior to initiating recruitment to those trials.)</p>

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Remote vs. In-Person Study Evaluation (RISE) Trial 1 of 3 to examine the impact of decentralized trial methods on accrual efficiency, retention, biospecimen capture, and treatment utilization: study protocol for a multi-center randomized controlled trial in the context of smoking cessation (RISE Above Smoking)

  • 期刊论文

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  • 发表日期：

    2026年7月31日

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  • Larry W. Hawk Jr.,
  • Robert A. Schnoll,
  • Jennifer Dahne,
  • Matthew J. Carpenter,
  • Karen L. Cropsey,
  • Gregory E. Wilding,
  • CeCe Duerr,
  • Caitlin G. Allen,
  • Van T. Nghiem,
  • Rachel C. Shelton,
  • Joseph Boccardo,
  • Casey D. Foster,
  • Martin C. Mahoney

摘要

Background

Remote trials (i.e., virtual or decentralized trials), in which patients receive some or all treatment and provide study data without the need to travel to a clinic or medical center, have emerged as a promising approach to conducting clinical trials. However, evidence for the hypothesized benefits of remote trials is weak, consisting primarily of anecdotal reports, uncontrolled studies, and expert opinion. The same is true for hypothesized limitations of remote trials such as technological barriers and aspects of trial rigor. A stronger evidence base is needed to evaluate the impact of remote trials.

Methods

Remote vs. In-Person Study Evaluation (RISE) was developed to examine the benefits and limitations of remote clinical trials and consists of separate randomized controlled trials (RCTs) for 3 different use cases. In RISE RCT 1 (RISE Above Smoking), the focus of this protocol paper, adults who smoke (AWS) cigarettes will be randomized to Remote vs. In-Person Intake Visit (written consent and eligibility screening). Intake-eligible participants will be re-randomized to Remote vs. In-Person Treatment and Assessment Visits. Recruitment will continue until 200 AWS initiate treatment. All participants will receive 8 weeks of combination nicotine replacement therapy (NRT; 14 or 21 mg transdermal nicotine patch, based on smoking rate, and 2 mg nicotine lozenges) and a printed self-help guide, and will be assessed through 3-month follow-up. Primary outcomes include accrual efficiency, retention, treatment utilization/adherence, and biospecimen completion rates. A key secondary clinical outcome (smoking cessation) will also be assessed. Subsequently, RISE RCTs 2 and 3 will employ harmonized timelines and outcomes in smaller (N = 100 participants who initiate treatment in each) single-site evaluations of remote vs. in-person trial components in different contexts: an mHealth intervention for people with depression symptoms and an opioid overdose education and naloxone intervention for people with opioid/stimulant use disorder.

Discussion

The RISE RCTs will provide novel, rigorous evidence regarding the impact of remote trial methods on trial efficiency and rigor, including the degree to which these effects generalize across clinical contexts and participant characteristics.

Trial registration

RCT 1 was preregistered on February 12 2025, on ClinicalTrials.gov, NCT06822049. https://clinicaltrials.gov/study/NCT06822049. (RCTs 2 and 3 will be registered prior to initiating recruitment to those trials.)