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Trial registered on ANZCTR


Registration number
ACTRN12622001042730
Ethics application status
Approved
Date submitted
11/07/2022
Date registered
26/07/2022
Date last updated
26/07/2022
Date data sharing statement initially provided
26/07/2022
Date results provided
26/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Text messages in psoriasis
Scientific title
Text messages as a reminder and educational tool in patients with psoriasis: A pilot study
Secondary ID [1] 307541 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 326975 0
Condition category
Condition code
Skin 324165 324165 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients actively seen via telemedicine at least every 2 weeks (convenience sampling) were invited to join the study. Randomization was done by a computer-generated random number list to group assignment, which was stored electronically. Patients assigned to the text message (TM) group received 7 TM per week (1 TM per day) whereas patients assigned to the control group received none all throughout the study. The patients in the TM group will be receiving 7 TM per week (1 TM per day) for a period of 12 weeks in the same randomly selected order (reminders three times weekly and educational tools four times weekly), as outlined by Balato et al in "Educational and motivational support service: a pilot study for mobile-phone-based interventions in patients with psoriasis" published in the British Journal of Dermatology last 2013. Each TM was 1-2 sentences in length, and was created using simple language, considering frequently asked questions about psoriatic drugs (e.g. administration, adverse effects) and general recommendations to take care of overall health.

Research participants were assessed in four study visits, one at the beginning and every 2 weeks thereafter until the eighth week. The following assessments were performed in all patients by the physicians: skin severity using Psoriasis Area and Severity Index (PASI), body surface area (BSA) and Physicians Global Assessment (PGA). After the skin evaluations, participants were asked to answer self-administered questionnaires that measured the following: quality of life using the Dermatology Life Quality Index (DLQI) and treatment adherence using the Medication Adherence Questionnaire (MAQ). An evaluation of the patient–physician relationship (through a 0–10 scale questionnaire) was also assessed during the first visit as baseline.

After 8 weeks of receiving daily TM, participants returned for a final evaluation and were asked to answer the same surveys, with added survey forms on evaluation of the patient–physician relationship and usability and satisfaction with TM interventions.

The physicians who observed and examined the patients were blinded to the TM or control group assignment. The primary investigator, on the other hand, was the one who enrolled, randomized, and sent daily TM to the patients. Furthermore, it was also the primary investigator who made the patients answer the patient-physician relationship satisfaction questionnaire at the end of the study.
Intervention code [1] 323998 0
Behaviour
Intervention code [2] 324043 0
Treatment: Other
Comparator / control treatment
Absence of text message
Control group
Active

Outcomes
Primary outcome [1] 331971 0
Change in treatment adherence as measured by the validated Medication Adherence Questionnaire (MAQ)
Timepoint [1] 331971 0
After 8 weeks of receiving text messages
Secondary outcome [1] 411771 0
Change in disease severity as measured by validated scoring tools such as PASI
Timepoint [1] 411771 0
After 8 weeks of receiving text messages
Secondary outcome [2] 411772 0
Change in patients' quality of life as measured by DLQI
Timepoint [2] 411772 0
After 8 weeks of receiving text messages
Secondary outcome [3] 411773 0
Change in patient–physician relationship as measured by a 0-10 scale questionnaire adapted from Patruno et al's study entitled, "Patient-physician relationship in patients with psoriasis" published in the Indian Journal of Dermatology, Venereology, and Leprology last 2012.
Timepoint [3] 411773 0
After 8 weeks of receiving text messages
Secondary outcome [4] 411774 0
Usability and satisfaction of text messages as a composite outcome through a four-item survey questionnaire adapted from Balato et al's study on "Educational and motivational support service: a pilot study for mobile-phone-based interventions in patients with
psoriasis" from the British Journal of Dermatology
Timepoint [4] 411774 0
After 8 weeks of receiving text messages
Secondary outcome [5] 411937 0
Change in disease severity as measured by validated scoring such as BSA
Timepoint [5] 411937 0
After 8 weeks of receiving text messages
Secondary outcome [6] 411938 0
Change in disease severity as measured by validated scoring tool such as PGA
Timepoint [6] 411938 0
After 8 weeks of receiving text messages

Eligibility
Key inclusion criteria
Patients whose PASI score were between 5 and 25 while receiving topical and physical or systemic treatment were included in this study. Other eligibility factors included the ability to acquire medications, ownership of a cellular phone, and the capacity to acknowledge the receipt of daily text messages.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with psoriasis who refuse to give and sign the consent form were excluded.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/09/2020
Date of last participant enrolment
Anticipated
Actual
25/11/2020
Date of last data collection
Anticipated
Actual
31/01/2021
Sample size
Target
34
Accrual to date
Final
33
Recruitment outside Australia
Country [1] 24888 0
Philippines
State/province [1] 24888 0

Funding & Sponsors
Funding source category [1] 311813 0
Self funded/Unfunded
Name [1] 311813 0
Jennifer Lavina T. Ngo
Country [1] 311813 0
Philippines
Primary sponsor type
Individual
Name
Jennifer Lavina T. Ngo
Address
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Country
Philippines
Secondary sponsor category [1] 313289 0
None
Name [1] 313289 0
Address [1] 313289 0
Country [1] 313289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311260 0
Rizal Medical Center - Institutional Review Board
Ethics committee address [1] 311260 0
Ethics committee country [1] 311260 0
Philippines
Date submitted for ethics approval [1] 311260 0
Approval date [1] 311260 0
18/09/2020
Ethics approval number [1] 311260 0

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

Contacts
Principal investigator
Name 120482 0
Dr Jennifer Lavina T. Ngo
Address 120482 0
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Country 120482 0
Philippines
Phone 120482 0
+639669839551
Fax 120482 0
Email 120482 0
jenniferngo.md@gmail.com
Contact person for public queries
Name 120483 0
Jennifer Lavina T. Ngo
Address 120483 0
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Country 120483 0
Philippines
Phone 120483 0
+632 88658400
Fax 120483 0
Email 120483 0
jenniferngo.md@gmail.com
Contact person for scientific queries
Name 120484 0
Jennifer Lavina T. Ngo
Address 120484 0
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Country 120484 0
Philippines
Phone 120484 0
+632 88658400
Fax 120484 0
Email 120484 0
jenniferngo.md@gmail.com

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 of published results only
When will data be available (start and end dates)?
July 2022 - July 2025
Available to whom?
Journal publishers
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Corresponding author:
Jennifer Lavina T. Ngo, MD
jenniferngo.md@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16600Ethical approval  jenniferngo.md@gmail.com



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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