Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001147673
Ethics application status
Approved
Date submitted
14/10/2014
Date registered
30/10/2014
Date last updated
27/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Smoke-Free Recovery from trauma surgery: A pilot trial of an online smoking cessation programme for trauma surgery patients.
Scientific title
A pilot trial of an online smoking cessation program investigating uptake and usage of an online smoking cessation programme.
Secondary ID [1] 285092 0
Nil
Universal Trial Number (UTN)
U1111-1159-9492
Trial acronym
SFR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking cessation among orthopaedic trauma patients requiring surgical intervention 292637 0
Condition category
Condition code
Public Health 292951 292951 0 0
Health promotion/education
Mental Health 293622 293622 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in will receive access to an online tailored smoking cessation program to help them quit smoking whilst they are in hospital and after discharge. Duration of participant enrolment will be up to two month post discharge from hospital. The program will provide easily accessible, interactive, tailored smoking cessation information and support in hospital without over-burdening the hospital staff. This smoking cessation intervention can be continued at home, with the individuals able to navigate freely through the program. The program will feature a low reading age, graphics and visuals where possible and will be available to participants indefinitely.
The program will be structured with seven modules to guide participants through the quit smoking process. These modules will include barriers to smoking cessation, tips on how to quit and stay quit as well as information on how to overcome relapse. The program will also feature interactive games, information about stop smoking medication, a discussion forum and a section for the individuals to track their progress. Participant will be able to access the program for the duration of their study enrolment, as the program is designed to be as close as possible to a real world interactive website which is available 24 hours a day on the internet.
Participants will have the opportunity to use the intervention program multiple times during their hospital stay, accessing it either on their own internet enabled device or on one of the study iPads. After the participants are discharged from hospital, they will continue to access the online program using their own internet enabled devices.
The program content will incorporate behaviour change techniques, tailoring and motivational interviewing to increase likelihood of effectiveness.
Participants will be followed up with one month after hospital discharge to determine their thoughts and rates of usage of the programme. Phone interviews will be conducted with participants lasting approximately five minutes
Intervention code [1] 289939 0
Behaviour
Comparator / control treatment
No comparator group used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292811 0
Self-reported programme usage during and after hospital admission.
Timepoint [1] 292811 0
Time point: At least one week after discharge
Secondary outcome [1] 309723 0
Self-reported smoking status- patient self-report
Timepoint [1] 309723 0
Time point: At least one week after discharge
Secondary outcome [2] 309724 0
Receipt of smoking cessation care during hospital admission- patient self-report at follow-up call.
Timepoint [2] 309724 0
Time point: At least one week after discharge

Eligibility
Key inclusion criteria
Eligibility criteria:
1. aged 18- 80 years old
2. Smokes tobacco cigarettes
3. Can read English
4. Has recently been admitted to the John Hunter or Liverpool Hospital for a fracture requiring surgery
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded from participating in this study if the individual is an elective surgical patient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A two step recruitment process was used.
Step 1: Consent to health behaviour survey
A Research Assistant (RA) on the ward will approach all fractures patients to complete an online health behaviours survey. Results from this survey will indicate to the RA that the individual may be eligible to take part in the study.
Step 2: Consent to Smoke-Free Recovery trial
The RA will screen individuals for eligibility using a Case Report Form which lists the eligibility and ineligibility criteria for Smoke-Free Recovery. If an individual is deemed eligible by the RA, they will be given the Participant Information Statement outlining the requirements of the study and a Consent Form which will need to be signed and returned before they are able to participate. Individuals will be given up to 72 hours (3 days) after their initial admission to hospital to return a signed Consent Form and complete the baseline survey.
Individuals will be allowed to use the iPad to access the online program at their own free will whilst in hospital.
Participants are contacted at least one week after discharge for a follow-up telephone call.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was removed during study recruitment due to difficulties finding eligible individuals.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
No sub-group analysis was conducted.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis:
From the results of follow-up phone calls, qualitative analysis will be used to determine themes based on rates of usage, changes in tobacco smoking and receipt of smoking cessation care following hospital discharge. A full statistical analysis plan will be developed at a later date.


Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/03/2015
Actual
9/03/2015
Date of last participant enrolment
Anticipated
Actual
22/09/2016
Date of last data collection
Anticipated
Actual
15/11/2016
Sample size
Target
710
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2800 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 2801 0
Liverpool Hospital - Liverpool

Funding & Sponsors
Funding source category [1] 289700 0
Government body
Name [1] 289700 0
National Health and Medical Research Council Partnership
Country [1] 289700 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 288393 0
Government body
Name [1] 288393 0
Hunter New England Health
Address [1] 288393 0
Lookout Rd, New Lambton NSW 2305
Country [1] 288393 0
Australia
Other collaborator category [1] 278075 0
Government body
Name [1] 278075 0
South West Sydney Local Area Health
Address [1] 278075 0
Eastern Campus Of Liverpool Hospital/Elizabeth St, Liverpool NSW 2170
Country [1] 278075 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291441 0
Hunter New England Health Human Research Ethic Committee
Ethics committee address [1] 291441 0
Ethics committee country [1] 291441 0
Australia
Date submitted for ethics approval [1] 291441 0
19/02/2014
Approval date [1] 291441 0
26/02/2014
Ethics approval number [1] 291441 0
HREC/14/HNE/46

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

Contacts
Principal investigator
Name 50374 0
Prof Billie Bonevski
Address 50374 0
University of Newcastle
1 University Drive
Callaghan
NSW 2308
Country 50374 0
Australia
Phone 50374 0
+612 40335710
Fax 50374 0
Email 50374 0
[email protected]
Contact person for public queries
Name 50375 0
Sam McCrabb
Address 50375 0
University of Newcastle
1 University Drive
Callaghan
NSW 2308
Country 50375 0
Australia
Phone 50375 0
61240335713
Fax 50375 0
Email 50375 0
[email protected]
Contact person for scientific queries
Name 50376 0
Sam McCrabb
Address 50376 0
University of Newcastle
1 University Drive
Callaghan
NSW 2308
Country 50376 0
Australia
Phone 50376 0
+61240335713
Fax 50376 0
Email 50376 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.