Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials
State University of New York at Buffalo
Summary
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Common to all 3 RCTs: Inclusion criteria: 1. age18+ years 2. 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) 3. able to read, speak \& verbally comprehend English 4. own an iOS or Android smartphone 5. 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)…
Interventions
- DrugCombination Nicotine Replacement Therapy (patch and lozenge)
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.
Locations (2)
- University at BuffaloBuffalo, New York
- University of PennsylvaniaPhiladelphia, Pennsylvania