A research study to assess the feasibility of evaluating a smoking cessation app that delivers 'context aware' advice in real time

Not Applicable

Completed

Conditions: Preventing smoking relapse, managing cue-induced cravings
Not Applicable

Registration Number: ISRCTN12326962

Lead Sponsor: niversity of East Anglia

Brief Summary: 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33903144/ (added 28/04/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37055073/ (added 16/10/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38676391/ (added 02/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 209

Inclusion Criteria

1. Current smokers (at least 7 cigarettes per week)
2. Willing to make a quit attempt in the next 14 days
3. Has primary use of an Android smartphone (version 5.0 and above)
4. Age 16 years and above
5. Resident in England
6. Able and willing to provide informed consent using the web-based form

Exclusion Criteria

1. Not previously participated in this trial
2. At present the app and related study materials are in English and so potential participants would require an understanding of basic written English in order to give informed consent and engage with the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As this is a feasibility trial there is no primary outcome. Outcomes will be collected to enable an estimation of key parameters to inform a future trial, in line with MRC guidance, and to provide preliminary information about the impact of the intervention:<br>1. Completeness of the anticipated primary outcome for a future definitive trial (self-reported abstinence with biochemical validation at 6.5 months post enrolment)<br>2. Cost per recruit, based on recruitment advertising costs gathered by the online recruitment company (Nativve) during the trial recruitment phase (February-March 2020)<br>3. Rates of app installation, use and support delivery fidelity measured using initialisation data recorded by the Quit Sense app during the period of participant engagement with the app (for approximately 3 months post enrolment in study)<br>4. Completion of smoking cessation-related resource use and quality of life (EQ-5D-5L) data at enrolment and in the 6.5-month online follow-up survey

Secondary Outcome Measures