Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001255976
Ethics application status
Approved
Date submitted
15/07/2020
Date registered
24/11/2020
Date last updated
24/11/2020
Date data sharing statement initially provided
24/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of text messaging support to aid smoking cessation in patients presenting for surgery (TextPOP)
Scientific title
Use of text messaging support to aid smoking cessation in patients presenting for surgery (TextPOP)
Secondary ID [1] 301517 0
Nil known
Universal Trial Number (UTN)
U1111-1253-5580
Trial acronym
TextPOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 317867 0
Condition category
Condition code
Mental Health 315911 315911 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will utilise deliver a m-Health smoking cessation intervention opportunistically targeted to a time point at which patients have been shown to be particularly receptive to behaviour change (before a surgical procedure).

The intervention for this project entails a text message program delivered to participants over a 12 week period of time, with 4 messages per week. The content of these text messages will include 24 smoking cessation messages and 24 general messages, which include 1) healthy lifestyle (i.e. diet and physical activity) and 2) information specific to Westmead Hospital pre-admission and surgical services (eg. Parking locations, typical clinic duration, items to bring etc.). The primary outcome of self-reported smoking cessation will be assessed at 12 weeks and 12 months.

Participants will be recruited via screening of recommendation for surgery documents at Westmead pre-admission clinic. At this point, our investigators based at Westmead hospital will contact the participants and fill out the initial questionnaire surrounding their current smoking habits and general health indices. The questionnaire data is recorded on the RedCap database which will then randomise the participants to the intervention or control group. Participants in the intervention group will receive text messages as above, via current software previously used to deliver text message based interventions in high risk cardiology patients (used for clinical trial TEXT ME). This intervention is delivered from the cardiology research department at Westmead hospital. At the end of the 12 week period - investigators will again contact the participants to fill out the follow up questionnaire regarding changes to smoking habits/smoking cessation/increased willingness to quit.

This research aims to establish the feasibility and effectiveness of a 12 week SMS delivered smoking cessation program delivered during the pre-operative waiting period before a scheduled surgical procedure.

The initial welcome message will be sent followed by 8 admin messages first. In the first week of the program there will be 4 messages and after that 3 messages per week. After the 8 admin messages the participants will receive 24 smoking cessation messages, 10 healthy lifestyle messages and 6 messages with information specific to Westmead Hospital pre-admission and surgical services.

The message delivery is monitored via an automated query to the messaging service provider. This query is performed for each message for 7 days after the message has been dispatched to determine whether the message has been delivered or not. This data is written to an excel spreadsheet.

Participants will be encouraged not to reply to the messages however any replies will be monitored and responded to as necessary. Participants will be able to opt out of the intervention at any time by replying to a message with the response 'STOP'.

If participants reply stop the messages will be ceased but they will still be contacted for followup. They will not be replaced as a drop off rate was factored into the power calculations.
Intervention code [1] 317825 0
Treatment: Other
Intervention code [2] 317826 0
Behaviour
Comparator / control treatment
The study participants will be randomised to either the intervention group which will receive a text message program to assist with smoking cessation, or a control group that will receive standard peri-operative communication only.

The controls will receive one message in the first week of the program, informing them that they are in the control group. In the last 4 weeks of the 12 week period they will receive 2 admin messages per week (8 admin messages in total).

Standard peri-operative communication includes information regarding pre-admission clinic and surgical services (eg. parking locations, typical clinic duration, items to bring etc.). This is relayed to patients typically via text message unless they do not have a mobile phone.
Control group
Active

Outcomes
Primary outcome [1] 324125 0
Number of participants who have successfully ceased smoking pre-operatively. Assessed using questionnaires specifically designed for this study.
Timepoint [1] 324125 0
12 weeks after intervention commenced
Secondary outcome [1] 383819 0
If smoking not ceased - change in willingness to quit. Assessed via post-intervention questionnaire - specifically 'are you more ready to quit now than you were 12 weeks ago?' with set responses; no, unsure, yes.
Timepoint [1] 383819 0
12 weeks after intervention commenced
Secondary outcome [2] 388029 0
Number of participants who have successfully ceased smoking pre-operatively. Assessed using questionnaires specifically designed for this study.
Timepoint [2] 388029 0
12 months after intervention commenced.

Eligibility
Key inclusion criteria
Inclusion criteria will be patients booked for surgical procedures in a large metropolitan hospital who have a self-reported history of smoking. Inclusion criteria include access to an active mobile phone and ability to understand written English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand English, no access to a mobile phone, surgery booked for less than 90 days time

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After recruitment and the completion of the initial study questionnaire, the data management system Redcap will randomise participants to either the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Methods
Statistical analysis will be conducted on the principle of intention to treat. Participants will be analysed by the original allocated groups. Statistical analysis will be conducted using SAS® software (version 9.4, SAS Institute Inc., Cary, NC, USA). Continuous variables will be reported as mean (standard deviation) or median (interquartile range), and compared using the t test or Mann-Whitney-Wilcoxon test. Categorical variables were reported as frequency (percentage), and compared using the chi-squared test or Fisher’s exact test. All statistical tests will be 2-tailed with a significance level of 5%. No adjustments for multiple comparisons will be made as the number of pre-defined outcomes is small. Subgroup analysis will be performed by clinical priority category.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/09/2020
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
1/11/2021
Actual
Sample size
Target
276
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16909 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 30562 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 305958 0
Hospital
Name [1] 305958 0
Westmead Hospital Cardiology Department
Country [1] 305958 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 306696 0
None
Name [1] 306696 0
Address [1] 306696 0
Country [1] 306696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306200 0
WSLHD Research Office
Ethics committee address [1] 306200 0
Ethics committee country [1] 306200 0
Australia
Date submitted for ethics approval [1] 306200 0
27/09/2018
Approval date [1] 306200 0
08/05/2019
Ethics approval number [1] 306200 0
AU RED HREC/18/WMEAD/365

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103066 0
Dr Aravinda Thiagalingam
Address 103066 0
Westmead Hospital Cardiology Department
Hawkesbury Road
Westmead NSW 2145
Country 103066 0
Australia
Phone 103066 0
+61 288905555
Fax 103066 0
Email 103066 0
[email protected]
Contact person for public queries
Name 103067 0
Kelly O'Shea
Address 103067 0
Westmead Hospital Anaesthetic Department
Hawkesbury Road
Westmead NSW 2145
Country 103067 0
Australia
Phone 103067 0
+61 288905555
Fax 103067 0
Email 103067 0
[email protected]
Contact person for scientific queries
Name 103068 0
Kelly O'Shea
Address 103068 0
Westmead Hospital Anaesthetic Department
Hawkesbury Road
Westmead NSW 2145
Country 103068 0
Australia
Phone 103068 0
+61 288905555
Fax 103068 0
Email 103068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8514Study protocol    380002-(Uploaded-01-10-2020-18-55-02)-Study-related document.docx
8515Informed consent form    380002-(Uploaded-19-08-2020-16-34-54)-Study-related document.pdf
8516Ethical approval    380002-(Uploaded-15-07-2020-22-22-28)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.