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Trial registered on ANZCTR


Registration number
ACTRN12621001719820
Ethics application status
Approved
Date submitted
20/10/2021
Date registered
16/12/2021
Date last updated
28/01/2024
Date data sharing statement initially provided
16/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of text messages on contact lens wearers' hygiene, engagement and satisfaction.
Scientific title
A randomised controlled trial evaluating the effects of behaviour change text messages on contact lens hygiene adherence, cessation rate and wearer satisfaction
Secondary ID [1] 305578 0
Nil
Universal Trial Number (UTN)
Trial acronym
TEXTCLEAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wearers with refractive error 323995 0
Condition category
Condition code
Public Health 321501 321501 0 0
Health promotion/education
Eye 321824 321824 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TXTCLEAN trial is designed as a randomised, controlled, double-blinded trial with two parallel groups and endpoints of 3 and 6 months.

The intervention messages have been created using peer-reviewed guidelines from global Optometric associations which have been modified using evidence-based behaviour-change techniques and refined by an expert review panel and contact lens lay-user focus groups.

Data collection using online self-report questionnaires (Qualtrics XM data capture platform) will be used for all participants. These procedures will occur at baseline, 3 months and at 6 months.

The intervention will be sequenced and sent using BURST SMS automated online messaging platform.

Examples of text messages include the following:

'Did you know that your fingers contain bacteria that can be transferred to your eyes when you put on contacts? One of the best ways to keep your vision clear and eyes healthy is handwashing with soap and water followed by proper drying.'

'Contacts can be so comfy that you may want to keep them in all night. Don’t be tempted! Key research shows that removing lenses before sleeping is important to keep your eyes healthy for life.'

The dose schedule for the test group is 4 text messages per week for the first 3 months followed by 2 messages per week for the final 3 months. The sequence of messages will be semi-personalised (using the participants first name and a reference to their chosen activity or sport where appropriate) and group-relevant (ensuring new wearers, existing wearers, daily disposable and reusable wearers receive appropriate messages). Personalisation will occur once baseline data is collected and extracted to ensure the correct personalised sequence is sent.

Evaluation using self-report questionnaires will include measures of fidelity (participant adherence to the intervention), complete delivery of the intervention, receipt of the text messages and the enactment (habit change applied to everyday life) of participants. A log of intervention delivery detailing the times the text messages were sent, what proportion were delivered successfully, and the click rate of links positioned within the text message.
Intervention code [1] 321978 0
Treatment: Other
Intervention code [2] 321979 0
Behaviour
Comparator / control treatment
The control group will receive a total of six text messages with content that relates to the administration of the trial only. The control group will not receive any other text messages in order to be as close to representing ‘usual care’ as possible.

Control group
Active

Outcomes
Primary outcome [1] 329273 0
Any change in 'contact lens hygiene adherence score'.

Measured by the self-report validated Contact Lens Study self Questionnaire (UNSW)
Timepoint [1] 329273 0
3 months and at 6 months since the start of the trial
Primary outcome [2] 329274 0
Change in '% cessation rate'

Measured by a self-report questionnaire, specifically designed for the purpose of this study
Timepoint [2] 329274 0
at 3 months and 6 months from the start of the trial
Primary outcome [3] 329275 0
Change in wearer 'combined satisfaction score'

Measured by an adapted American Consumer Satisfaction Index questionnaire.
Timepoint [3] 329275 0
at 3 months and 6 months from the start of the trial.
Secondary outcome [1] 401981 0
A composite secondary outcome of the feasibility and wearer acceptability of a sequence of text messages.

Measured by a process evaluation questionnaire designed specifically for this trial.
Timepoint [1] 401981 0
6 months after the start of the trial. Test group only

Eligibility
Key inclusion criteria
Currently wearing contact lenses full time, or part time
Over 18 years of age
Must own a mobile phone
Will be situated in Australia for the majority of the next 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Soft and Rigid lens wearers who have been advised regular overnight wear by their optometrist.
Scleral and Hybrid lens wearers
Bandage lens wearers
Contact lens wearers who use cosmetic lenses as their main/habitual type of lens, including coloured lenses
Other therapeutic lens wearers such as drug delivery lenses

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation
schedule who is “off-site”
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using sealedenvelope.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation, using PASS(2020) to detect a difference in hygiene adherence pre-post scores of 4 in the text group and 0 in the control group, with SD=9.4 at time 1 and 2, we need 106 participants in total, assuming 80% power and alpha of 0.05. Assuming a 30% attrition, we will recruit 151 participants.

Hygiene adherence and wearer satisfaction are continuous scores with expected normal distributions and will be investigated using linear mixed models. Cessation will be examined in a generalised linear mixed model with binary outcome and logit link.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/01/2022
Actual
17/01/2022
Date of last participant enrolment
Anticipated
25/03/2022
Actual
25/05/2022
Date of last data collection
Anticipated
20/12/2022
Actual
20/12/2022
Sample size
Target
151
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 35614 0
2036 - Eastgardens
Recruitment postcode(s) [2] 35615 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 309947 0
University
Name [1] 309947 0
UNSW
Country [1] 309947 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSW Sydney,
High St
Kensington,
NSW 2052
Country
Australia
Secondary sponsor category [1] 310987 0
None
Name [1] 310987 0
None
Address [1] 310987 0
Country [1] 310987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309658 0
The University of New South Wales Human Research Ethics Committee A
Ethics committee address [1] 309658 0
Ethics committee country [1] 309658 0
Australia
Date submitted for ethics approval [1] 309658 0
05/10/2021
Approval date [1] 309658 0
12/11/2021
Ethics approval number [1] 309658 0
HC210797

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

Contacts
Principal investigator
Name 114934 0
Dr Nicole Carnt
Address 114934 0
School of Optometry and Vision Science
UNSW Sydney
High St
Kensington, NSW 2052
Country 114934 0
Australia
Phone 114934 0
+61 2 9065 0387
Fax 114934 0
Email 114934 0
n.carnt@unsw.edu.au
Contact person for public queries
Name 114935 0
Nicole Carnt
Address 114935 0
School of Optometry and Vision Science
UNSW Sydney
High St
Kensington, NSW 2052
Country 114935 0
Australia
Phone 114935 0
+61 2 9065 0387
Fax 114935 0
Email 114935 0
n.carnt@unsw.edu.au
Contact person for scientific queries
Name 114936 0
Nicole Carnt
Address 114936 0
School of Optometry and Vision Science
UNSW Sydney
High St
Kensington, NSW 2052
Country 114936 0
Australia
Phone 114936 0
+61 2 9065 0387
Fax 114936 0
Email 114936 0
n.carnt@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified individual participant data will not be available for this study.
This trial will have ethics approval for sharing of results with participants, publication in journals, conferences and forming part of a Thesis.


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.