PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol 349 10 questionnaires are also taken at baseline: nicotine dependency (Fagerström scale),19 readiness-to-quit (Prochaska stages of change)20 and present bias (Kirby discontinuity scale).21, 29 See table 2 for a schematic overview of data collection during the trial. Participants will be sent reminders after five days for uncompleted questionnaires. A follow-up reminder will be sent two days later. If there are still open items, participants will be contacted by telephone two days after the last reminder and a follow-up phone call will be made another two days later. Table 2: Schematic overview of data collection during the trial. Questionnaire Baseline t = 0 months t = 3 months t = 6 months t = 12 months* t = 15 months Demographic variables X Fagerström scale X Prochaska stage of change X Kirby discontinuity scale X Willingness to pay a deposit X EQ-5DF** X X X X X X SASEQ*** X X X X X X Perceived stress scale X X X X X X Self-reported abstinence*** * X X X X X X Evaluation training sessions X Evaluation PERSIST X *t = 12 months is the primary endpoint ** EurQol Five Dimensions Health Questionnaire *** Smoking abstinence self-efficacy questionnaire **** The self-reported abstinence questionnaire is adjusted to each corresponding time moment, e.g. at t =3 the maximum period not smoked is three months etc. Data management Informed consent will be provided digitally through LimeSurvey (LimeSurvey GmbH, Hamburg, Germany). All trial data will be entered electronically using GemsTracker (GemsTracker ©, Erasmus MC and Equipe Zorgbedrijven, Rotterdam, the Netherlands). Data are handled confidentially and stored anonymously. Where data need to be linked to an individual subject (e.g. linking longitudinal data), a subject identification code will be used. The code will not be based on patient initials and date of birth to preserve anonymity. The key to the code will be safeguarded by the investigator and kept separate from data files. All of the study essential documents will be retained and archived for 15 years after
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