Phase 2/3Completed
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)
Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials
- Sponsor
- State University of New York at Buffalo (Academic or other)
- Enrolment
- 200 enrolled
- Conditions
- Remote vs. In-Person; Remote Visits; In-person Visits
- Interventions
- Combination Nicotine Replacement Therapy (patch and lozenge)
- Ages
- adults, older adults
- Registry
- NCT06822049
From the registry
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.
Primary outcomes
- Accrual efficiency/Pre-treatment visits
- Trial Quality: Retention
- Trial Quality: Treatment adherence/utilization (patient-reported)
- Trial quality: Biospecimen completion rates