Feasibility and optimisation of NRT support delivery and measurement
Research type
Research Study
Full title
Feasibility testing and optimisation of a prototype nicotine replacement therapy (NRT) adherence intervention (NAI) for pregnant women
IRAS ID
254560
Contact name
Tim Coleman
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The aim of this study is to refine and optimise a prototype nicotine adherence intervention (NAI) to help pregnant women who smoke to make better use of nicotine replacement therapy (NRT) in order to help them quit. The prototype intervention will include a one-to-one cessation support meeting followed by ongoing telephone, leaflet, website and SMS support intended to encourage users to take their NRT as directed. The intervention will be delivered alongside usual NHS stop smoking support for pregnant women. The prototype intervention will be delivered initially to a group of up to 10 participants (pregnant women undergoing a smoking quit attempt). After 4 weeks of use, participants will be asked to give feedback on the usability and acceptability of the intervention and to suggest ways in which it might be improved. Interviews and closed-ended questions will be used for this; we will also look at participants' use of different intervention features such as the website. Participants will also be asked to give their views on our data collection methods, including an app to report their NRT use. Participants will be asked to provide a saliva sample and breath test before and during the intervention in order to explore their nicotine and carbon monoxide levels respectively. Feedback from the initial group of participants will be used to make improvements to the intervention before it is delivered to a subsequent group of up to 10 pregnant women who smoke, and so on (up to 4 successive groups will test the intervention). At the end of the study we will have an optimised intervention and data collection methods for use in a future trial.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0193
Date of REC Opinion
7 Aug 2019
REC opinion
Further Information Favourable Opinion