Condition category
Mental and Behavioural Disorders
Date applied
07/01/2016
Date assigned
11/01/2016
Last edited
23/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The aim of this study is to test whether a new method to help people quit their tobacco use is better than the methods currently offered by primary health care providers (i.e. family doctors) in Sweden. The method specifically targets primary healthcare centres in Stockholm where tobacco use is more common, where the local population are likely to be poorly paid, not be as well-educated and suffer from poorer health when compared to the general population. The study also aims to determine whether this new method is worth its cost.

Who can participate?
Adult Swedish or Arabic speaking patients with Swedish social security numbers and permanent resident permits, without cognitive impairment, who use tobacco on a daily basis, visit participating primary healthcare centres and who are not already undergoing treatment for tobacco cessation.

What does the study involve?
The primary healthcare centres participating in this study are assigned to either the intervention or control group. Participants who attend centres in the control group are given their usual treatment. This includes counselling and drug (nicotine replacement) therapy. Participants who attend centres in the intervention group are treated according to the “tobacco cessation on prescription” programme. The main difference between the treatment for this group and the control group is that the counselling and drug therapy services offered are individually prescribed. They are also given information on other ways to help them quit their tobacco use (for example, doing exercise and finding other ways to cope with withdrawal symptoms) and self-help resources (such as smartphone apps, web-based counseling and websites that have more information and support). All participants are followed up after 6 and 12 months to see whether they have quit their tobacco use.

What are the possible benefits and risks of participating?
Participants will be offered support to quit their tobacco use. Quitting tobacco use can be a stressful experience since it can cause short term withdrawal symptoms and psychological stress. However, counselling on coping strategies and therapies that can help ease withdrawal symptoms will be given to avoid discomfort for participants. Participants that successfully quit their tobacco use should experience an improvement in both short and long-term health and quality of life.

Where is the study run from?
14-20 primary healthcare centres located in socioeconomically disadvantaged areas in Stockholm County (Sweden)

When is the study starting and how long is it expected to run for?
January 2015 to August 2019

Who is funding the study?
1. Stockholm County Council (Sweden)
2. Skandia Life Insurance (Sweden)
3. The Public Health Agency of Sweden (Folkhälsomyndigheten) (Sweden)

Who is the main contact?
1. Dr Tanja Tomson (scientific)
tanja.tomson@ki.se
2. Miss Anne Leppänen (public)
anne.leppanen@ki.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tanja Tomson

ORCID ID

http://orcid.org/0000-0002-4577-4304

Contact details

Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden
+46 (0)852 480 173
tanja.tomson@ki.se

Type

Public

Additional contact

Miss Anne Leppänen

ORCID ID

http://orcid.org/0000-0003-4273-4072

Contact details

Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden
+46 (0)852 483 612
anne.leppanen@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluating the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription in Swedish primary healthcare targeting socioeconomically disadvantaged areas in Stockholm - the "Motivation 2 Quit" (M2Q) study, a cluster-randomised controlled trial

Acronym

M2Q

Study hypothesis

Compared to standard treatment tobacco cessation on prescription is an effective and cost-effective treatment in achieving 7-day abstinence from tobacco use at 6 months after intervention among tobacco users visiting primary healthcare centres located in socioeconomically disadvantaged areas in Stockholm.

Ethics approval

Regional Ethical Review Board in Stockholm, April 2015, ref: 2015/207-31, 2015-1226-32, 2016/2080-32

Study design

An interventional pragmatic cluster-randomised controlled trial.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Smoking

Intervention

Participants are randomly allocated to either tobacco cessation on prescription or standard treatment according to which primary healthcare centre (PHC) they attend.

1. Tobacco cessation on prescription is defined as:
1.1. Tobacco cessation counselling (minimum 10 minutes) provided by a qualified healthcare professional in combination with
1.2. A prescription for individualised tobacco cessation treatment, including options for:
1.2.1. Further counselling (referral to healthcare provider with more competence or the Swedish Quit Smoking Line)
1.2.2. Pharmacotherapy (nicotine replacement therapy, varenicline, bupropion)
1.2.3. Other measures for tobacco cessation (physical activity and other strategies to cope with withdrawal symptoms)
1.2.4. Follow-up (by telephone or revisit)
1.2.5. Support for self-management (reference to mobile applications, web-based counselling and websites for more information and support). The approach will be individualised in the sense that providers will discuss the available treatment options, contraindications, preferences and other relevant circumstances with the patient and then decide together on which treatment alternative(s) suit the individual best.
3. Follow-up of the prescription by the prescriber on at least one occasion is also included in the intervention.

Standard treatment is defined as:
Current treatment practices for tobacco cessation at the participating PHC in the control group and include different types of counselling and pharmacotherapy. The major difference between the trial conditions is how the counselling is administered (with or without a prescription form).

Participating PHC centres will be randomised with a 1:1 ratio to either intervention- or control conditions. Cluster-randomisation will be employed at the PHC centre level, meaning that all study participants recruited from a particular PHC centre will receive the same treatment (tobacco cessation treatment either with or without tobacco cessation on prescription).

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Point prevalence of 7-day abstinence (total abstinence from tobacco use during the 7 days preceding follow-up) at 6 months after the intervention

Secondary outcome measures

1. Point prevalence of 7-day abstinence at 12 months after the intervention
2. Daily tobacco consumption (number of cigarettes), at 6 and 12 months after the intervention
3. Number of quit attempts and health-related quality of life (on a scale from 0-1 where 0 represents death and 1 represents perfect health) at 6 and 12 months after the intervention
4. Cost effectiveness, measured as the incremental cost per quality-adjusted life year

All outcomes will be based on self-reports from patient questionnaires.

Overall trial start date

01/01/2015

Overall trial end date

31/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Swedish or Arabic speaking daily tobacco users with Swedish social security number and permanent resident permit
2. Over 18 years of age
3. Visiting participating primary health care centres in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

14-20 primary healthcare centres with 43 participants from each centre

Participant exclusion criteria

1. Ongoing treatment for tobacco cessation
2. Cognitive impairment affecting ability to participate in the study on a voluntary basis

Recruitment start date

01/02/2016

Recruitment end date

31/08/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Valsta Medical Centre (Valsta Vårdcentral)
Hammargatan 6
Märsta
195 53
Sweden

Trial participating centre

Norrtälje Northern Medical Centre (Norrtälje Norra Vårdcentral)
Lasarettsgatan 6
Norrtälje
761 45
Sweden

Trial participating centre

Hallstaviks Medical Centre (Hallstaviks Vårdcentral)
Carl Wahrens väg 24
Hallstavik
763 34
Sweden

Trial participating centre

Capio Primary Care Centre Hagsätra (Capio Vårdcentral Hagsätra)
Hagsätra torg 7B
Bandhagen
124 73
Sweden

Trial participating centre

Capio Primary Care Centre Wasa (Capio Vårdcentral Wasa)
Prästgårdsvägen 4
Södertälje
151 61
Sweden

Trial participating centre

Cevita Care - Rimbo-Edsbro family doctors (Husläkarna Rimbo-Edsbro)
Stockholmsvägen
Rimbo
762 31
Sweden

Trial participating centre

Capio Primary Care Centre Skogås (Capio Vårdcentral Skogås)
Melodivägen 6
Skogås
142 40
Sweden

Trial participating centre

Capio Primary Care Centre Vårberg (Capio Vårdcentral Vårberg)
Vårbergstorget 5
Skärholmen
127 43
Sweden

Trial participating centre

Handens Medical Centre (Handens Vårdcentral)
Dalarövägen 6
Handen
136 46
Sweden

Trial participating centre

Family Doctors Husby (Familjeläkarna Husby)
Edvard Griegsgången 13
Kista
164 32
Sweden

Trial participating centre

Hallonbergens Medical Centre (Hallonbergens Vårdcentral)
Hallonbergsplan 7
Sundbyberg
174 52
Sweden

Trial participating centre

Fisksätra Medical Centre (Fisksätra Vårdcentral)
Fisksätra torg 20
Saltsjöbaden
133 41
Sweden

Trial participating centre

The Health Medical Centre Tensta (Hälsans Vårdcentral Tensta)
Tenstagången 18
Spånga
163 64
Sweden

Trial participating centre

Liljeholmens Medical Centre (Liljeholmens Vårdcentral)
Liljeholmstorget 7
Stockholm
117 63
Sweden

Trial participating centre

Rinkeby Medical Centre (Rinkeby Vårdcentral)
Skårbygränd 3
Spånga
163 72
Sweden

Trial participating centre

Vårbergs Medical Centre (Vårbergs Vårdcentral)
Vårbergsplan 31
Skärholmen
127 43
Sweden

Trial participating centre

Skärholmens Medical Centre (Skärholmens Vårdcentral)
Storholmsgatan 19
Skärholmen
127 48
Sweden

Trial participating centre

Solna City Medical Centre (Solna Centrum Vårdcentral)
Hotellgatan 3
Solna
171 45
Sweden

Sponsor information

Organisation

Karolinska Institute (Karolinska Institutet) (Sweden)

Sponsor details

Tomtebodavägen 18A
Stockholm
17177
Sweden

Sponsor type

University/education

Website

http://www.ki.se

Funders

Funder type

Government

Funder name

Stockholms Läns Landsting

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Skandia Life Insurance (Livförsäkringsbolaget Skandia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Public Health Agency of Sweden (Folkhälsomyndigheten)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists intend to publish the study protocol during the spring of 2016 and the study results in the beginning of 2019. The cost-effectiveness analysis is expected to be published in 2020. In addition to publications in scientific journals, the results will be disseminated to the scientific community through presentations at national and international conferences. The results will also be disseminated to study participants, funders, policy makers and the general public through oral presentations, written reports and popular scientific summaries.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available because the trialists do not have consent to share this information.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27637517

Publication citations

Additional files

Editorial Notes

23/04/2018: IPD sharing statement added. 16/04/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/06/2017 to 31/08/2018. 2. The overall trial end date was changed from 01/06/2018 to 31/08/2019. 3. Trial participating centres added. 4. The intention to publish date was changed from 01/06/2019 to 31/12/2019. 19/09/2016: Publication reference added. 03/06/2016: The Public Health Agency of Sweden (Folkhälsomyndigheten) was added as a funder.