Mobile phone-based smoking cessation intervention for patients with elective surgery
| ISRCTN | ISRCTN33869008 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33869008 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/08/2018
- Registration date
- 04/10/2018
- Last edited
- 27/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Several large studies have shown that the risk of cardiovascular (heart), respiratory (lung), and wound-healing complications (including death) within 30 days of surgery is greater for smokers than non-smokers. However, there is evidence that even short-term smoking cessation may reduce morbidity (illness) after surgery. Structural problems and scarcity of time and resources lead to patients at most Swedish surgical departments simply being told that they should quit, and perhaps being referred to a primary health care clinic. An SMS (text message)-based smoking cessation aid can be effective in helping individuals quit smoking, but is also a very simple and time efficient tool for surgical departments to administer. The aim of this study is to fill the knowledge gap on whether or not an SMS-based smoking cessation intervention can be effective at helping patients stop smoking before surgery. This study aims to assess the effectiveness of the SMS-based intervention on smoking behaviour as an additional tool on top of current routine treatment.
Who can participate?
Adult patients undergoing elective surgery
What does the study involve?
Participants are randomly allocated to one of two groups. One group is given access to the new SMS intervention, while the other group is not given access to the intervention. Both groups have access to the surgical departments’ current routine for smoking cessation before surgery. Smoking outcomes are measured through questionnaires after 3, 6, and 12 months.
What are the possible benefits and risks of participating?
This trial will collect data on the effectiveness of the intervention, increasing the evidence on SMS-based interventions for smoking cessation. One group is given a new intervention which is hoped to improve their chances of quitting smoking, but the researchers are not withholding any other treatment that individuals in the intervention or control group wish to use. All participants are free to use any service currently existing, but only the intervention group will receive the new intervention. There are therefore no immediate risks, but a potential benefit for patients that are allocated to the intervention group.
Where is the study run from?
20 surgical departments in south-east Sweden
When is the study starting and how long is it expected to run for?
September 2017 to October 2021
Who is funding the study?
Kamprad Family Foundation (Sweden)
Who is the main contact?
Dr Marcus Bendtsen
Contact information
Scientific
Linköping University
Linköping
58183
Sweden
 ORCID ID |
0000-0002-8678-1164 |
|---|
Study information
| Study design | Two-arm parallel-group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Mobile phone-based smoking cessation intervention for patients with elective surgery – a randomised controlled trial |
| Study acronym | NEXit OPR |
| Study hypothesis | Smoking cessation rates will be higher among individuals given access to a mobile phone-based intervention, compared to individuals without access. |
| Ethics approval(s) | Regionala etikprövningsnämnden i Linköping: avdelningen för prövning av övriga forskning, 10/10/2018, dnr 2018/316-31 |
| Condition | Smoking among patients with elective surgery |
| Intervention | All patients with elective surgery will be invited to the trial. One group will be given access to the mobile phone-based program delivered via SMS, including interactive component, while the other group will be told that they will not be given access to the intervention. Both groups will be told that they have access to the surgical departments’ current routine for smoking cessation prior to surgery. Smoking outcomes will be measured through questionnaires at 3, 6, and 12 months after randomisation. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at 3, 6 and 12 months after randomisation using self-reported questionnaires: 1. Prolonged abstinence (not smoking more than 5 cigarettes the past 8 weeks). 8 weeks is adjusted to 5 and 11 months at 6- and 12-months follow-up 2. Point prevalence (not smoking any cigarette the past 4 weeks) |
| Secondary outcome measures | Measured at 3, 6 and 12 months after randomisation using self-reported questionnaires: 1. 7-day point prevalence (no cigarettes the past 7 days) 2. The number of quit attempts since joining the study 3. Number of cigarettes smoked per week (if still smoking) |
| Overall study start date | 01/09/2017 |
| Overall study end date | 15/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 434 |
| Participant inclusion criteria | All patients undergoing elective surgery will be invited to the trial (not children or neonatal) |
| Participant exclusion criteria | Not owning a mobile phone or non-smoker |
| Recruitment start date | 15/10/2018 |
| Recruitment end date | 15/10/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Sweden
Sponsor information
Charity
Familjen Kamprads stiftelse, Västra Esplanaden 3
VÄXJÖ
352 30
Sweden
| Website | http://familjenkampradsstiftelse.se/in-english/ |
|---|---|
"ROR" |
https://ror.org/03qb1q739 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Kamprad Family Foundation
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | A trial protocol will be submitted for review prior to the first patient being recruited. Data from the 3-month follow-up will be used to author an efficacy article regarding short-term effects in the beginning of 2020. Data from 6- and 12-month follow-up will be used to author an efficacy article regarding long-term effects in the beginning of 2022. |
| IPD sharing plan | Data will be archived on university servers. Due to GDPR the trialists are not allowed to hand over data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/03/2019 | 27/03/2019 | Yes | No |
Editorial Notes
27/03/2019: Publication reference added.
16/10/2018: Ethics approval details added.
