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Trial registered on ANZCTR


Registration number
ACTRN12618001089224
Ethics application status
Approved
Date submitted
19/06/2018
Date registered
29/06/2018
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SCAMPI – Smoking Cessation App for (Chinese) Male smokers: Pilot Intervention trial
Scientific title
SCAMPI – Smoking Cessation App for (Chinese) Male smokers: Pilot Intervention trial
Secondary ID [1] 295249 0
None
Universal Trial Number (UTN)
Trial acronym
SCAMPI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 308417 0
Condition category
Condition code
Mental Health 307406 307406 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to intervention group will be offered the full version of SCAMPI programme as a smoking cessation tool. The programme consisted with two parts including SCAMPI WeChat Official Account for sending users quitting messages, as well as SCAMPI mini-programme for helping users to make quitting plan and track their quitting progress. SCAMPI WeChat Official Account will be programmed to send regular quitting tips to participants in intervention group. Participants can review the past messages and read the up-to-date messages whenever they want. The SCAMPI mini-programme will allow participants to create their quitting plan, track their quitting progresses, and evaluate their progresses via doing lung function screening.
Participants will be encouraged to read quitting tips on the SCAMPI WeChat Official Account and use the SCAMPI mini-programme. However, participants can determine the level of usage by their own. Participants are expected to spend 3~5 minutes per week over a 6-week period to provide their smoking statuses to the research team. Notification will be sent through WeChat messages to instruct participants how to take action to provide their smoking statuses. After providing their smoking statuses, participants will be offered with "WeChat Red Pocket" (e-currency). Fix amount of e-currency will be allocated in "WeChat red pocket" and offered by 7 sessions (including baseline assessment and 6 weeks of smoking status data collection). The whole process of the trial will be completely automatic and via social network platform.
Intervention code [1] 301584 0
Behaviour
Comparator / control treatment
Participants allocated in control group will be offered to have access to a restricted version of the SCAMPI programme. The restricted version will only have the SCAMPI WeChat Official Account for sending users contacts of China smoking cessation service (e.g. Quitline and Smoking Cessation Service). Participants are expected to spend 3~5 minutes per week over a 6-week period to provide their smoking statuses to the research team. Notification will be sent through WeChat messages to instruct participants how to take action to provide their smoking statuses. After providing their smoking statuses, participants will be offered with "WeChat Red Pocket" (e-currency). Fix amount of e-currency will be allocated in "WeChat red pocket" and offered by 7 sessions (including baseline assessment and 6 weeks of smoking status data collection). The whole process of the trial will be completely automatic and via social network platform.
Control group
Active

Outcomes
Primary outcome [1] 306376 0
The primary outcome of this pilot trial will be participants’ bio-verified 30-day smoking abstinence at 6-week follow-up. At the 6-week time point, researchers will review and analyse participants’ (in both groups) smoking status in the past 30 days to identify their 30-day smoking abstinence at the planned time point. The 30-day smoking abstinence is usually used as the primary outcome measure for smoking cessation intervention trials recommended by the Society for Research on Nicotine and Tobacco (SRNT). Quit failure is defined as any cigarettes smoked in the past 30 consecutive days. This measurement is also known as the 10th level of smoking abstinence in the Chinese Standard for smoking cessation. At the 6-week time point, a Nicotine Cotinine Saliva Test kit will be sent to participants (in both groups) who report themselves with 30-day smoking abstinence to verify their smoking abstinence status.
Timepoint [1] 306376 0
Assessed weekly after randomisation for 6 weeks
Secondary outcome [1] 348427 0
Participants’ cigarette consumption reduction. Participants who reduce consumption of over 50% from baseline will be counted as successfully achieve smoking reduction. This outcome will be measured based on participants self-reported data through social network platform.
Timepoint [1] 348427 0
Assessed weekly after randomisation for 6 weeks
Secondary outcome [2] 348428 0
Prolonged smoking abstinence at 6-week follow-up. The prolonged smoking abstinence is defined as participants record no smoking following the first 7 days after the intervention start till the end of the study. The relevant data for measuring this outcome will be self-reported by participants and be collected through social network platform.
Timepoint [2] 348428 0
Assessed weekly after randomisation for 6 weeks
Secondary outcome [3] 348429 0
7-day smoking abstinence at 4-week – At the 4-week time point, researchers will review and analyse participants’ (in both groups) smoking status in the past 7 days to identify their 7-day smoking abstinence at this time point. 7-day smoking abstinence is defined as not a single cigarette being smoked in the past 7 days. The relevant data for measuring this outcome will be self-reported by participants and be collected through social network platform.
Timepoint [3] 348429 0
At 4 weeks after randomisation
Secondary outcome [4] 348430 0
7-day smoking abstinence at 6-week – At the 6-week time point, researchers will review and analyse participants’ (in both groups) smoking status in the past 7 days to identify their 7-day smoking abstinence at this time point. 7-day smoking abstinence is defined as not a single cigarette being smoked in the past 7 days. The relevant data for measuring this outcome will be self-reported by participants and be collected through social network platform.
Timepoint [4] 348430 0
At 6 weeks after randomisation
Secondary outcome [5] 365455 0
Participants’ compliance with SCAMPI programme. Participants’ compliance refers to participants (in both groups) provide their weekly smoking status (self-reported through social network platform) at the end of every week, as well as answering the end-of-trial questionnaires (including VAS for assessing their acceptability and MARS for assessing their satisfaction levels).
Timepoint [5] 365455 0
Assessed weekly after randomisation for 6 weeks
Secondary outcome [6] 365456 0
Number of times participants visiting SCAMPI programme. At the end of the pilot trial, researchers will review and analyse the frequencies of participants visiting the SCAMPI programme. This data will be available on the server of the programme shown as "frequencies of visit".
Timepoint [6] 365456 0
Assessed weekly after randomisation for 6 weeks
Secondary outcome [7] 365457 0
Number of times participants interacting with the SCAMPI programme. At the end of the pilot trial, researchers will review and analyse the data of how many times participants (in intervention group) like, comment, forward, post content from SCAMPI programme through their social network accounts.
Timepoint [7] 365457 0
Assessed weekly after randomisation for 6 weeks
Secondary outcome [8] 365458 0
Participants’ acceptability of using SCAMPI as their smoking cessation tool. Participants’ acceptability (for both groups) of using SCAMPI will be measured by a VAS questionnaire at the end of the pilot trial. Participants’ acceptability to the SCMAPI programme will be asked by questions such as “Did the programme increase your willingness to stop smoking”, and “Did the programme encourage you to look for more stop smoking techniques?”. Each question will be answered by a 5-item scale from “Not at all” to “Very much”.
Timepoint [8] 365458 0
At 6 weeks after randomisation
Secondary outcome [9] 365459 0
Participants’ satisfaction level of using SCAMPI as their smoking cessation tool. Participants’ satisfaction level (for both groups) of using SCMAPI will be measured by a Mobile Application Rating Scale questionnaire at the end of the pilot trial.
Timepoint [9] 365459 0
At 6 weeks after randomisation

Eligibility
Key inclusion criteria
Chinese male smokers will be eligible for inclusion in the study if they indicate at screening that they are smokers (both daily smokers “smoking any types of tobacco products on a daily basis” or occasional smokers “smoking any types of tobacco products occasionally”) between 25-44 years of age; have access to a smartphone; have a WeChat account; process adequate knowledge of Chinese language; and are willing to participate in the study and provide follow-up information at scheduled points of the study.
Minimum age
25 Years
Maximum age
44 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
People that do not meet the inclusion criteria will be excluded from the study.

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)
Randomisation will be performed at the individual level. Participants (N=318) that fulfil entry criteria and have completed baseline assessment will be randomised at a 1:1 ratio to either a intervention group or to a control group. The final randomisation lists will be concealed in the database until the point of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by the trial statistician using block randomisation with variable block sizes of 2 or 4.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
control panel for the data in related to the SCAMPI OA usage; (2) Wenjuanxin (it is an online questionnaire that is embed into WeChat OA system) control panel for the data in related to baseline assessment and weekly smoking status; and (3) the lean cloud database for the data in related to SCAMPI mini-programme usage. Extracted data will be entered into an Excel Database, and following cleaning and datalock, exported into SAS (version 9.4) for analysis.
Baseline characteristics
Baseline data collected from all participants will be summarised by occasional smoker and daily smoker. Continuous variables (e.g. average daily cigarette consumption) will be presented as numbers observed, means and standard deviations. Categorical variables (e.g. marital status) will be presented as frequencies and percentages. Since any differences between randomised groups at baseline could only have occurred by chance, no formal significance testing will be conducted.
Outcome relevant data
Primary and secondary outcomes will be first summarised descriptively at identified time points. Generalised linear mixed model will be used to assess the effect of the SCAMPI programme to participants’ smoking cessation outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10572 0
China
State/province [1] 10572 0

Funding & Sponsors
Funding source category [1] 299838 0
University
Name [1] 299838 0
University of Auckland
Address [1] 299838 0
261 Morrin Rd, St Johns, Auckland 1072
Country [1] 299838 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
261 Morrin Rd, St Johns, Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 299191 0
None
Name [1] 299191 0
Address [1] 299191 0
Country [1] 299191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300715 0
University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 300715 0
261 Morrin Rd, St Johns, Auckland 1072
Ethics committee country [1] 300715 0
New Zealand
Date submitted for ethics approval [1] 300715 0
20/12/2018
Approval date [1] 300715 0
21/12/2018
Ethics approval number [1] 300715 0
021649

Summary
Brief summary
This project evaluates a mobile smoking cessation programme, called as “SCAMPI”, which consists of a social network subscription account (SCAMPI WeChat Official Account) and a social network based app (SCAMPI mini-programme). The SCAMPI programme was developed based on the preferred features (functions, user experience and user interface) of its target end--users (Chinese male smokers aged 25 to 44 years).
This project will be implemented fully online. The evaluation will be run as a two-arm randomised controlled trial (RCT). After providing e-consents, participants will be randomly allocated to two groups. Participants allocated to intervention group will be offered the full version of SCAMPI programme (3 months intervention) while participants allocated to control group will be offered with restricted version of SCAMPI programme, which provides contact to general Chinese smoking cessation care (including Chinese Quitline and Local smoking cessation clinics).
Smoking status of participants from both groups will be measured weekly over a 3-month period. Participants’ prolonged smoking abstinence over the evaluation period will be used to assess the effectiveness of the SCAMPI programme for helping people to quit smoking. At the end of the project, participants will be asked about their satisfaction levels with the SCAMPI programme. Participants from both groups will be offered the SCAMPI programme with free-of-charge for supporting them to quit smoking after the study complete.
Trial website
Trial related presentations / publications
Public notes
Attachments [2] 2784 2784 0 0
http://www.anzctr.org.au/AnzctrAttachments/375381-SCAMPI Stage 2 ICF.docx (Participant information/consent)

Contacts
Principal investigator
Name 84582 0
Prof Chris Bullen
Address 84582 0
National Institute for Health Innovation, 261 Morrin Rd, St Johns, Auckland 1072
Country 84582 0
New Zealand
Phone 84582 0
+64021415267
Fax 84582 0
Email 84582 0
c.bullen@auckland.ac.nz
Contact person for public queries
Name 84583 0
Mr Jinsong Chen
Address 84583 0
National Institute for Health Innovation, 261 Morrin Rd, St Johns, Auckland 1072
Country 84583 0
New Zealand
Phone 84583 0
+640220951065
Fax 84583 0
Email 84583 0
jinsong.chen@auckland.ac.nz
Contact person for scientific queries
Name 84584 0
Mr Jinsong Chen
Address 84584 0
National Institute for Health Innovation, 261 Morrin Rd, St Johns, Auckland 1072
Country 84584 0
New Zealand
Phone 84584 0
+640220951065
Fax 84584 0
Email 84584 0
jinsong.chen@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All participants in this study will be anonymised.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 902 0
Study protocol
Citation [1] 902 0
Link [1] 902 0
Email [1] 902 0
Other [1] 902 0
Type [2] 903 0
Informed consent form
Citation [2] 903 0
Link [2] 903 0
Email [2] 903 0
Other [2] 903 0
Type [3] 904 0
Ethical approval
Citation [3] 904 0
Link [3] 904 0
Email [3] 904 0
Other [3] 904 0
Type [4] 905 0
Ethical approval
Citation [4] 905 0
Link [4] 905 0
Email [4] 905 0
Other [4] 905 0
Summary results
No Results