Condition category
Mental and Behavioural Disorders
Date applied
16/03/2015
Date assigned
22/03/2015
Last edited
20/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nicotine replacement therapy (NRT) has been shown to be effective at helping people quit smoking in numerous clinical trials. However, the effectiveness of quit attempts with NRT purchased over-the-counter (OTC) is very low in the UK, which may be due to poor adherence to guidelines on NRT use. Therefore, stop smoking interventions focused on the use of OTC NRT could also increase the quit rates. Smartphone-based interventions delivered through applications, or apps, could be used to deliver support both for smoking cessation as well as NRT use as part of a quit attempt. However, to date no such intervention has been developed or evaluated. This study aims to test if a new app that was developed by researchers at University College London (UCL) and which focused on the use of NRT as part of a quit attempt could increase abstinence from smoking and use of NRT. The performance of the app will be compared with a reduced version of the app that offers only a minimal support with planning and monitoring of the quit attempt and brief advice on quitting, but which does not have features and extensive advice dedicated to smoking cessation and use of NRT.

Who can participate?
Adults aged at least 18, currently smoking at least 10 cigarettes per day, and who live in the UK. They should also have bought any nicotine replacement therapy (e.g., gums or sprays) over the counter, and be interested in stopping smoking completely in the next 2 weeks, and be able to use a new app for iPhone to help them.

What does the study involve?
The study compares two versions of an app for quitting smoking with NRT (either a single product, or a combination of a patch with another nicotine product, such as gums or sprays). When participants download the app and register into the study the app randomly allocates them to one of its two versions, which they will then use to support them though an attempt to quit smoking. Version 1 of the app (control) allows users to set up the date to quit (within two weeks of joining the study) and provides brief information on quitting smoking and use of nicotine replacement therapy that might help them in their attempt to stop smoking. The user can also monitor their progress in terms of for how many days they have stopped smoking. The app also sends users reminders to use the app that can be disabled. Version 2 (intervention) offers the same features as version 1. In addition, it also provides comprehensive advice on smoking cessation (including information on craving management, preparation of quit attempt, and the available cessation support). It also includes an extensive suite of interactive features and comprehensive advice to assist with use of NRT products selected by participants, including text-based guides, and tools for monitoring of daily NRT use, and feedback on NRT use. All participants in both groups select a quit date within 2 weeks of signing up to the study after which they try to quit smoking completely and use NRT as recommended. After 8 weeks participants are asked some questions via the app, and are contacted by e-mail and phone if they do not respond via the app. They are contacted again 7 months since registration by email, and if they do not respond then also by phone with few questions. At 8 weeks since the registration, participants who report that they have not smoked in the previous 4 weeks will be invited to provide small samples of saliva via post. Some participants may be invited to a follow-up interview study about their experiences with the app.

What are the possible benefits and risk of participating?
By taking part in the study, participants are more likely to quit smoking, which would be one of the most beneficial things that one can do to improve health. They will also receive access to a new and free app for quitting smoking with NRT. Participants invited to provide saliva samples will receive a gift voucher of £20. Participants may experience some withdrawal symptoms such as irritability or increased hunger when they try to quit smoking. Those who are using NRT may also experience some side effects, but these tend to be short-lived and not dangerous.

When is the study starting and how long is it expected to run for?
From March 2015 to March 2016.

Where is the study run from?
The study is conducted remotely on smartphones in the UK, and is managed by researchers at Health Behaviour Research Centre at University College London (UK).

Who is funding the study?
1. Pfizer (through a grant award scheme, GRAND, that is run by a panel of independent scientists with no decision-making input from Pfizer)
2. British Heart Foundation PhD Studentship (UK)

Who is the main contact?
Miss Aleksandra Herbec (Trial Lead), aleksandra.herbec.11@ucl.ac.uk
Tobias Raupach (Principal Investigator), t.raupach@ucl.ac.uk.

Trial website

Contact information

Type

Scientific

Primary contact

Miss Aleksandra Herbec

ORCID ID

http://orcid.org/0000-0002-3339-7214

Contact details

Health Behaviour Research Centre
Rm 215
Research Department of Epidemiology and Public Health
University College London
London
WC1E 7HB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial to evaluate the effectiveness of a smartphone-based smoking cessation intervention focused on promoting adherence to nicotine replacement therapy

Acronym

PANTHERS (Promoting Adherence to Nicotine THERapy for Smoking cessation)

Study hypothesis

1. The intervention will increase abstinence rates at short-term follow-up in comparison with the control condition. Specifically, it is predicted that there will be an effect size of OR=1.7, or 5% difference in the primary outcome – a prolonged complete 4-week abstinence from smoking prior to follow-up scheduled at 8 weeks since registration between intervention and control conditions (13% vs 8%, respectively), verified biochemically using salivary cotinine (or anabasine levels among participants reporting using electronic cigarettes or nicotine replacement therapy at the time of providing saliva samples).

2. The intervention will also result in greater NRT use, as well as higher satisfaction ratings, greater frequency of app use, and higher long-term quit rates.

Ethics approval

University College London Research Ethics Committee, 14/02/2014, ref: 5398/001.

Study design

Two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Cigarette smoking

Intervention

Participants are randomised to either the intervention or control condition. Both conditions provide participants with access to a free app developed for iOS (8.0+). All trial participants are followed up at 8 weeks and 7 months after registering into the trial.

The control app constitutes a ‘minimum credible intervention’ that provides the users with advice and tools for setting up a quit date within two weeks of registering, a possibility to change the quit date, as well as very brief advice on quitting smoking, craving management and use of NRT selected by the users, and information about the study. It also allows users to track their progress in terms of the number of days passed since the quit date.

The intervention version of the app offers the same features as the control app, but in addition it offers comprehensive advice on NRT selected by users that focuses on addressing potential causes of non-adherence (particularly intentional non-adherence), as well as interactive features for reporting, monitoring, and receiving feedback on daily use of NRT and smoking status. It also offers comprehensive text-based advice on smoking cessation, including advice on planning and preparing for the quit, management of cravings, problem solving, use of available cessation aids, and fostering identity of a non-smoker. Additionally, it includes daily tips with additional advice and encouragement (including daily tips for up to 14 days before the quit date), more information about the research team and the rationale for the focus on NRT use, as well as customisable daily reminders to use the app.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The primary outcome will be self-report of not smoking in the 4 weeks prior to the follow up scheduled for 8 weeks since registration, and biochemically verified by saliva cotinine level of <15 ng/mL, or by a saliva anabasine level of <1 ng/ml among those reporting using nicotine replacement therapy or electronic cigarettes.

Participants lost to follow up will be presumed to have resumed smoking.

Secondary outcome measures

1. Self-reported abstinence rates during the 4 weeks prior to the follow-up scheduled for 8 weeks after registration (complete abstinence, and rates of smoking 5 cigarettes or less)
2. Self-reported use of nicotine replacement therapy since the registration, assessed at 8-week follow-up
3. Self-reported use of other cessation medications and support at 8-week follow-up
4. Satisfaction ratings of the intervention at 8-week follow-up
5. Quantitative indices of app use (e.g., number of times the app was opened)
6. Self-reported criteria required for the Russell Standard (RS6): self-reported continuous 6-month abstinence assessed at 7-month follow-up, defined as having no more than 5 cigarettes in the past 6 months and no cigarettes in the previous week
7. Self-reported 7-day point-prevalence abstinence assessed at 7-month follow-up.

Overall trial start date

01/01/2013

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Currently living in the UK
2. 18 years or older
3. A daily smoker (at least 10 cigarettes/day)
4. Purchased at least one nicotine replacement therapy product available in the UK (i.e., patches, gums, lozenges, microtabs, nasal or mouth spray, inhalator, or oral strips) over the counter
5. Interested to quit smoking completely (not just to cut down)
6. Has regular access to a relevant smartphone device (iOS) with access to the internet
7. Download and try using the suggested app to help them quit
8. Agree to be contacted via the app, e-mail or telephone at 8 weeks and 7 months after the registration
9. Agree to take part in testing of saliva samples, if invited.
10. Have no contraindications for NRT use (determined by the participants, for example in consultation with the pharmacist)
11. Not currently pregnant or breastfeeding

Participants also have to provide informed consent to participate in the study, accept the End User Licence Agreement & Privacy Policy, and complete the registration into the trial via the app.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 1186 participants, with at least 593 participants in each condition, will be recruited. The sample size was calculated a priori, with alpha set to 5% (two-tailed), and power to 80%. The sample size was set to detect an expected effect size of OR=1.7, or of 5% difference in self-reported abstinence rates at 4 week follow-up, with the abstinent rates in the control condition predicted to be 8% (in the control) and expected rates of 13% (intervention). Recruitment into the main trial will stop when both groups will have 593 or more eligible participants. Due to the nature of recruitment (self-selection and registration via the app), the recruitment may continue past 1186 participants, but any additional participants recruited (including participants reporting having purchased NRT on prescription) will be included only in the secondary and sensitivity analyses.

Participant exclusion criteria

1. Does not meet inclusion criteria
2. Only data from the first registration with the app will be included
3. Obtains NRT on prescription

Recruitment start date

23/03/2015

Recruitment end date

01/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Behaviour Research Centre at UCL
Research Department of Epidemiology and Public Health University College London
London
WC1E 7HB
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Health Behaviour Research Centre
Research Department of Epidemiology and Public Health
University College London
London
WC1E 7HB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Pfizer GRAND 2013 Award (http://grand2014.org/previous_grand_awards/)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Heart Foundation PhD Studentship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are hoping to publish the results by summer 2016 (but this might be done in two papers - to be confirmed). We will also likely also publish the protocol (probably submit in the next month).

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes