Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000664448
Ethics application status
Approved
Date submitted
2/05/2016
Date registered
23/05/2016
Date last updated
26/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can the uptake of smoking cessation support be increased through text messages?
Scientific title
'Evaluation of positive response rates to SMS text messages offering support for smoking cessation
Secondary ID [1] 289080 0
Nil
Universal Trial Number (UTN)
U1111-1178-2404
Trial acronym
TICTOC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 298528 0
Condition category
Condition code
Public Health 298618 298618 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: In addition to usual care (see control below) patients who do not respond will receive another message in four weeks time. This message will be slightly different to the first, but will ask them to respond. A third message will be sent to patients who do not respond in another four weeks. The second and third messages will be different in that it will acknowledge that we have already sent a previous text and this is a follow-up and it will enable people to opt out of further messages.

Intervention 2: In addition to usual care (see control below) patients will receive a text message with a hyperlink to the YouTube video will be sent to patients four weeks after the usual care text message. A GP from one of the study practices will record a brief (30-60 seconds) motivational message to patients who smoke. The motivational message will contain the following: a brief introduction by the GP recording the message, including a short message on the benefits of quitting and then an offer of support to quit, including a brief description of the support available. The video will be uploaded onto YouTube. A template will be designed that will help GPs to deliver this message.
Intervention code [1] 294590 0
Lifestyle
Comparator / control treatment
Usual care: A single SMS text message sent to current smokers asking them to (a) confirm current smoking status and (b) ask if they would like help in stopping smoking in the following way

‘Hi [PAT_FIRSTNAME], [PAT_PROV]s nurse updating our records. Are you still smoking, would you like help to quit? Reply what suits best. Help me quit. Not ready to quit yet. Quit in the last year. Quit over a year ago.’
Control group
Active

Outcomes
Primary outcome [1] 298108 0
'Proportion of smokers who respond with "help me quit" to a question asking if they would like help in stopping smoking through SMS text message'
Timepoint [1] 298108 0
Three months after the first SMS usual care text message is sent.
Secondary outcome [1] 323199 0
Proportion of smokers who respond to the message.

The proportion of smokers who respond to the message will be measured by collecting incoming text messages.
Timepoint [1] 323199 0
Within three months after the first SMS usual care text message is sent.
Secondary outcome [2] 323917 0
Patient feedback on the intervention.

Patient feedback on the intervention will be assessed by asking patients to respond to two text messages:
(a) Was it appropriate to receive the message from your doctor? (Reply Y or N)
(b) Did it increase your motivation to quit? (Score range 0 not at all to 5 extremely)
Timepoint [2] 323917 0
Three months after the first SMS usual care text message is sent.

Eligibility
Key inclusion criteria
1. 25 years of age or over
2. Recorded as a current smoker in the Practice Management System
3. Have a mobile phone number without any advised restriction of contact
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. less than 25 years of age or over
2. do not have a mobile phone number

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2016
Actual
1/06/2016
Date of last participant enrolment
Anticipated
23/08/2016
Actual
1/08/2016
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
714
Accrual to date
Final
714
Recruitment outside Australia
Country [1] 7840 0
New Zealand
State/province [1] 7840 0

Funding & Sponsors
Funding source category [1] 293456 0
Government body
Name [1] 293456 0
New Zealand Ministry of Health
Country [1] 293456 0
New Zealand
Primary sponsor type
Other
Name
Whanganui Regional Health Network
Address
100 Heads Rd,
Whanganui 4501
Country
New Zealand
Secondary sponsor category [1] 292279 0
None
Name [1] 292279 0
Address [1] 292279 0
Country [1] 292279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294901 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 294901 0
Ethics committee country [1] 294901 0
New Zealand
Date submitted for ethics approval [1] 294901 0
08/01/2016
Approval date [1] 294901 0
21/03/2016
Ethics approval number [1] 294901 0
16/NTB/13

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

Contacts
Principal investigator
Name 65398 0
Dr John McMenamin
Address 65398 0
Wicksteed Medical Centre
220 Wicksteed Street
Whanganui 4500
Country 65398 0
New Zealand
Phone 65398 0
+646 349 1800
Fax 65398 0
Email 65398 0
[email protected]
Contact person for public queries
Name 65399 0
John McMenamin
Address 65399 0
Wicksteed Medical Centre
220 Wicksteed Street
Whanganui 4500
Country 65399 0
New Zealand
Phone 65399 0
+646 349 1800
Fax 65399 0
Email 65399 0
[email protected]
Contact person for scientific queries
Name 65400 0
Hayden McRobbie
Address 65400 0
The Dragon Institute for Innovation
PO Box 28854
Remuera
Auckland 1541
Country 65400 0
New Zealand
Phone 65400 0
+6421476247
Fax 65400 0
Email 65400 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.