Tobacco addiction Other
Conditions
Interventions
This is a randomised controlled trial to assess the effects of very brief, opportunistic, smoking cessation advice compared to usual care, provided by financial guidance services to adults receiving s
common pitfalls which may hinder delivery
and how these might be best managed or avoided. There will also be approximately 100 control group consultations for fidelity testing.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Able to give informed consent to participate. 2. Adults aged 18 years or over regardless of if they have any medical conditions or if they are pregnant. 3. Currently receiving advice or support for financial difficulties by financial guidance services. 4. Self-reported daily tobacco smoking, regardless of motivation to quit smoking. 5. People who can provide a phone number and/or email address and a postal address to be contacted at, for the purposes of follow-up.
Exclusion criteria
Exclusion criteria: 1. People using only smokeless tobacco, heated tobacco, shisha, cannabis, or non-tobacco nicotine products like e-cigarettes or nicotine pouches. People using these products alongside daily tobacco smoking will still be eligible. 2. Only one person per household may be enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Biochemically validated four-week prolonged abstinence from tobacco at 12 weeks post-randomisation. Saliva samples will be tested for cotinine and/or anabasine dependent on the use of non-tobacco nicotine post-quit attempt. 2. Biochemically validated prolonged abstinence from tobacco between the 12-week and 9-month follow-ups. Saliva samples will be tested for cotinine and/or anabasine dependent on the use of non-tobacco nicotine post-quit attempt. 3 . Self-reported 7-day point prevalence tobacco abstinence at 12-weeks and 9-month follow-ups. 4. Serious adverse events (SAEs) at 12-week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimate the intervention’s cost-effectiveness relative to usual care from the public sector perspective. This will be judged based on 4 outcome measures: 1.1. Financial well-being, measured using the abbreviated Consumer Financial Protection Bureau scale at 12-weeks and 9-month follow-ups. 1.2. Health-related quality of life, measured using the EuroQol EQ-5D-5L at 12-weeks and 9-month follow-ups. 1.3. Incremental cost per QALY gained at 12-weeks and 9-month follow-ups. 1.4. Mental well-being, measured using the Warwick-Edinburgh Mental-Wellbeing Scale at 12-weeks and 9-month follow-ups. Embedded process evaluation investigating factors, e.g., number of quit attempts and intervention acceptability, influencing effects of the intervention. This will be judged based on 10 outcome measures: 2.1. Proportion making at least one quit attempt (defined as 24-hours or more of abstinence) – self reported at 12-weeks and 9-month follow-ups. 2.2. Change in number of self-reported cigarettes smoked per day between baseline and follow-ups at 12-weeks and 9-month follow-ups. 2.3. Proportions of smoke-free households (defined as none of the members of a household currently smoking tobacco), self-reported at 12-weeks and 9-month follow-ups. 2.4. Self-reported change in tobacco expenditure from baseline to follow-ups at 12-weeks and 9-month follow-ups. 2.5. Intervention fidelity at 12-weeks and 9-month follow-ups. 2.6. Intervention acceptability at 12-weeks and 9-month follow-ups. 2.7. Self-reported follow-on smoking cessation behavioural support, e-cigarette and medication use (including length of use) at 12-weeks and 9-month follow-ups. 2.8. Participants’ experiences of the intervention post-baseline (during the follow-up period). 2.9.Service advisors’ experiences of the intervention post-baseline (during the follow-up period). 2.10. If the intervention is delivered as intended (and what may hinder or support this) post-baseline (during the follow-up period). | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactAngela Wu
Outcome results
None listed