No registrations found.
Source
Brief title
Health condition
None
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Seven-day point prevalence after 12 months
Secondary outcome
Seven-day point prevalence after 1 & 6 months, evidence-based cessation assistance use after 1 months, 6 months and 12 months, decisional conflict right after using the decision aid
Background summary
We developed a web-based decision aid (DA) to 1) motivate smokers to apply evidence-based cessation support tools when quitting and to 2) helps smokers to choose smoking cessation support tools that are in line with their personal preferences. This DA will be tested in a randomized controlled trial (RCT).
Study objective
H1a/b/c is that a DA with an explicit value clarification method (VCM) and tailored advice will lead to a statistically significant increase in smoking abstinence after 1 month (H1a), 6 months (H1b), and 12 months (H1c) compared to a DA without an explicit VCM and tailored advice: direct effect on smoking abstinence.
H2a/b/c is that a DA with an explicit VCM and tailored advice will lead to a statistically significant increase in evidence-based cessation assistance use after 1 month (H2a), 6 months (H2b), and 12 months (H2c) compared to a DA without an explicit VCM and tailored advice.
H3a/b is that the positive effect of a DA with an explicit VCM and tailored advice (vs a DA without an explicit VCM and tailored advice) on smoking abstinence after 6 months and 12 months will be at least partially mediated by the use of evidence-based cessation assistance at 1-month (H3a) and 6-month (H3b) follow-ups, respectively: indirect effect on smoking abstinence.
H4 is that a DA with an explicit VCM and tailored advice will lead to a statistically significant decrease in decisional conflict (state of uncertainty about which course of action to take) right after the DA compared to a DA without an explicit VCM and tailored advice.
H5 is that a decision aid with an explicit VCM and tailored advice will lead to an increase in both value clarification as well as in experienced autonomy, together this will lead to an increase in perceived competence which ultimately leads to a decrease in regret. However, the latter effect is moderated by cessation success.
In addition, it will also be tested whether the DA is more cost-effective compared to a DA without the explicit VCM component.
Study design
Baseline (before and after intervention), after 1 month, after 6 months, and after 12 months
Intervention
Decision aid with an explicit value clarification method and advice
Inclusion criteria
Smoking, intention to quit within 6 months, 18 years or older, being able to read and understand Dutch
Exclusion criteria
Not smoking, no intention to quit within 6 months, younger than 18 years, not being able to read and understand Dutch
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8270 |
Other | Medical Ethics Committee Zuyderland, the Netherlands : 16-N-227 |