Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT05209451
Eligibility Criteria:
Inclusion Criteria:
* A Mayo Clinic Midwest patient (Mayo Clinic Rochester or Mayo Clinic Health System \[MCHS\]) with a Mayo Clinic number.
* Aged 18 years or older.
* Can read and speak in the English language. Based on 2019 data, 97% of our Rochester and MCHS patients speak English. The study will provide all participants with a smoking cessation program delivered through the Mayo Clinic patient portal. Currently, Mayo Clinic's portal services are not offered in languages other than English.
* Has a Minnesota, Iowa, or Wisconsin address currently or at date of most recent visit to Mayo Clinic.
* Rural resident based on RUCA codes derived from ZIP code of current or last known address.
* Has access to a telephone of any type (e.g., landline, smartphone). Access to a telephone is needed to complete the coaching support intervention and to follow-up with participants if there are issues with accessing the patient portal for the smoking cessation intervention.
* Current smoker defined as one or more cigarettes (even a puff) smoked in the past 30 days (original criteria). This definition allows for enrollment of non-daily and/or light smoking enhancing the generalizability. In addition to cigarettes, cigarillos and cigars are combustible tobacco products and thus relevant as a focus for our study. Thus, the protocol was modified with IRB approval to change this criterion to include other combustible tobacco use. The final criterion was "Current smoker defined as one or more cigarettes, cigarillos, or cigars (even a puff) smoked in the past 30 days." To enhance the generalizability of our findings, we will enroll participants using other tobacco/nicotine products if cigarette, cigarillo or cigar smoking is the primary product used
* For past 3 months not enrolled in a program or use of cessation pharmacotherapy (original criterion). The protocol was modified with IRB approval to allow for ad hoc use to enhance generalizability. The final criterion was "For past 3 months not enrolled in a program or use of cessation pharmacotherapy other than ad hoc use, for example used nicotine gum or lozenge once or twice."
* Willing to make a quit smoking attempt.
* Has a patient portal account, or is willing to create a patient portal account.
* Has an email address to provide to study staff, or is willing to create an email address.
* Has digital access barriers defined by one or more of the following:
1. based on participant ZIP code from current or last known address geocoded census block group indicates area of poor BB internet coverage; (b) no existing Mayo Clinic patient portal account or (c) has a Mayo Clinic patient portal account but has not used it in the past 5 years; (d) self-reports having no access to broadband (high speed) internet connection for personal use; and/or (e) self-reports low digital literacy defined with the screening question "How comfortable are you using technology to manage your health care remotely? For example, using patient online services (i.e., patient portal) to schedule appointments, check for test results, or send a message to your provider?" (included: not at all or a little comfortable).
Exclusion Criteria:
* Anyone not meeting all inclusion criteria will be excluded.
* Has participated in a behavioral smoking cessation program in the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05209451
Study Brief:
Protocol Section:
NCT05209451