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Trial registered on ANZCTR


Registration number
ACTRN12624000498594
Ethics application status
Approved
Date submitted
28/03/2024
Date registered
23/04/2024
Date last updated
23/04/2024
Date data sharing statement initially provided
23/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of text messaging in improving care for psoriasis patients
Scientific title
Cardiovascular health text messages and influence on patient activation, knowledge and cardiovascular risk factors in patients with psoriasis
Secondary ID [1] 311842 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TEXTME PSO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 333374 0
Condition category
Condition code
Cardiovascular 330066 330066 0 0
Coronary heart disease
Metabolic and Endocrine 330067 330067 0 0
Metabolic disorders
Diet and Nutrition 330068 330068 0 0
Obesity
Skin 330268 330268 0 0
Dermatological conditions
Inflammatory and Immune System 330270 330270 0 0
Autoimmune diseases
Public Health 330272 330272 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of educative and lifestyle based text messages aimed at CVD prevention including; diet, physical activity, smoking cessation (if relevant), weight, compliance with psoriasis treatment, general cardiovascular health information and psoriasis education, delivered over 26 weeks (approximately six months).

The participants can respond to text messages, which will be relayed to study investigators and attended to as needed. They will not be encouraged to respond to messages.
The language used in the text messages encourage behaviour change and are educational, informative, motivational and supportive in intent. In some messages links to online resources are provided for additional information or for re-enforcement. Examples of these include: links to the heart foundation website, the American academy of dermatology and dermNet.
Cardiovascular health content is aligned with Australia cardiovascular health clinical practice and guidance from the National Heart Foundation. Content is all additionally reviewed by local clinicians for alignment with Australian practice.
The frequency of the text messages is 4x/week.
We monitor whether text messages are delivered. An end of program feedback form is also administered routinely to assess participant uptake, response and feedback.
Intervention code [1] 328301 0
Prevention
Intervention code [2] 328302 0
Lifestyle
Intervention code [3] 328303 0
Behaviour
Comparator / control treatment
The control group will receive usual care and will not receive the text-message based program. Usual care consists of routine psoriasis/biologic clinic visits where the clinic doctor and/ or psoriasis nurse may provide educative advice to psoriasis patients regarding cardiovascular risk and recommend a patient see their GP for cardiovascular risk factor screening.
Control group
Active

Outcomes
Primary outcome [1] 337825 0
Change in Patient Activation
Timepoint [1] 337825 0
Baseline and 26 weeks post baseline (appproximately 6 months)
Secondary outcome [1] 433405 0
Systolic blood pressure
Timepoint [1] 433405 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [2] 433406 0
Total cholesterol (TC)
Timepoint [2] 433406 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [3] 433408 0
Haemoglobin A 1 C
Timepoint [3] 433408 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [4] 433409 0
Body Mass Index (BMI)
Timepoint [4] 433409 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [5] 433410 0
Composite variable of physical activity (moderate and vigorous, walking) metabolic equivalents of time (METS), as per the international physical activity questionaire (IPAQ). This will be assessed as a composite outcome.
Timepoint [5] 433410 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [6] 433411 0
Mediterranean diet score
Timepoint [6] 433411 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [7] 433413 0
Psoriasis medication adherence
Timepoint [7] 433413 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [8] 433414 0
Psoriasis and Cardiovascular disesase knowledge - this is a single secondary outcome (knoweldge based assessment)
Timepoint [8] 433414 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [9] 433419 0
Psoriasis severity
Timepoint [9] 433419 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [10] 433420 0
Psoriasis quality of life assessment
Timepoint [10] 433420 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [11] 434118 0
low density lipoprotein (LDL)
Timepoint [11] 434118 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [12] 434119 0
Triglycerides (TG)
Timepoint [12] 434119 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [13] 434120 0
high denisty lipoprotein (HDL)
Timepoint [13] 434120 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [14] 434134 0
Sedentary activity time (as assessed by the IPAQ)
Timepoint [14] 434134 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [15] 434135 0
Smoking status: cigarettes smoked in the last 7 days
Timepoint [15] 434135 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [16] 434136 0
Smoking quitting attempts
Timepoint [16] 434136 0
Baseline and 26 weeks post-baseline (approximately 6 months)
Secondary outcome [17] 434137 0
Intention to quit smoking
Timepoint [17] 434137 0
Baseline and 26 weeks post-baseline (approximately 6 months)

Eligibility
Key inclusion criteria
Participants must meet ALL of the following inclusion criteria:
• Aged 18 years or older
• Have documented evidence of a diagnosis of psoriasis (chronic plaque type) by a dermatologist
• Have an active mobile phone, that can receive text messages, with internet access (to be able to access educative links via text-messages)
• Proficiency of the English language to consent and read text messages
• Willingness and ability to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to follow up for the duration of the study due to frailty, geographical, physical or social reasons
• Pregnant/Lactating women
• Recent myocardial infarction, unstable angina or stroke (< 3 months)

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)
Participants will be informed of their allocation via text message but will be asked not to reveal their allocation status to their clinician or research investigators contacting them for the study. Researchers will not be made aware of patient allocation until unblinding. Allocation concealment will be achieved via central randomisation by a computer-generated device.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will take place via a computerised randomisation program in a 1:1 allocation ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
With PAM-13 as the primary outcome in this study, based on previously published PAM 13 data in the chronic disease space including CKD space, we expect a standard deviation of 14.4. A mean difference in score of 8.4 would be clinically meaningful so with a SD of 14.4, using a 5% level of significance, with 1:1 randomisation, and allowing for a 10% drop out we need a sample size of 100 (48 per group) to achieve 80% power. Of note a difference of 4 points is deemed the minimal clinically significant difference in PAM13, and an increase in 3 to 6 points over time has been associated with improved health behaviours and outcomes.

Participant demographics and clinical characteristics will be analysed using descriptive statistics. Continuous variables will be summarised by mean and standard deviation, median and interquartile limits whereas categorical variables by frequencies and percentages. An adjusted regression analysis will assess the treatment effect on PAM13.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
Date of last participant enrolment
Anticipated
11/06/2024
Actual
Date of last data collection
Anticipated
17/12/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26342 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 42315 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 316188 0
Commercial sector/Industry
Name [1] 316188 0
Sun pharma
Country [1] 316188 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 318374 0
None
Name [1] 318374 0
Address [1] 318374 0
Country [1] 318374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315007 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315007 0
Ethics committee country [1] 315007 0
Australia
Date submitted for ethics approval [1] 315007 0
22/01/2024
Approval date [1] 315007 0
01/02/2024
Ethics approval number [1] 315007 0
156917

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

Contacts
Principal investigator
Name 133406 0
Dr Annika Smith
Address 133406 0
Westmead Hospital, Cnr Hawkesbury Rd and Darcy Rd, Westmead NSW 2145
Country 133406 0
Australia
Phone 133406 0
+61 288908060
Fax 133406 0
Email 133406 0
[email protected]
Contact person for public queries
Name 133407 0
Annika Smith
Address 133407 0
Westmead Hospital, Cnr Hawkesbury Rd and Darcy Rd, Westmead NSW 2145
Country 133407 0
Australia
Phone 133407 0
+61288908060
Fax 133407 0
Email 133407 0
[email protected]
Contact person for scientific queries
Name 133408 0
Annika Smith
Address 133408 0
Westmead Hospital, Cnr Hawkesbury Rd and Darcy Rd, Westmead NSW 2145
Country 133408 0
Australia
Phone 133408 0
+61288908060
Fax 133408 0
Email 133408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Following publication, beginning 3 months and ending 5 years following main results publication
Available to whom?
Researchers, who propose a methodologically sound proposal, on a case by case basis, following approval from study investigators and at the discretion of the primary sponsor
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approval by Principal Investigator [email protected]


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.