Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001039774
Ethics application status
Approved
Date submitted
11/07/2022
Date registered
25/07/2022
Date last updated
20/07/2023
Date data sharing statement initially provided
25/07/2022
Date results information initially provided
20/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Social media intervention in patients with psoriasis
Scientific title
The effect of social media intervention as a reminder and educational tool on treatment adherence in patients with psoriasis: A randomized controlled trial
Secondary ID [1] 307524 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 326956 0
Condition category
Condition code
Skin 324140 324140 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research participants will be assigned to either control or intervention. Those assigned to intervention will be further subdivided into two; the first group will be receiving messages through Facebook thrice a week whereas the second group will be receiving messages once a week. Those belonging to the intervention group will be receiving messages for a period of twelve weeks in alternating order of reminder-education-reminder.

Messages containing reminders and knowledge of the disease were created using simple language, considering frequently asked questions about pathogenesis, clinical manifestations, comorbidities, prognosis, and general recommendations to take care of overall health. These were adapted from Balato et al's study entitled, "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 and Bardazi et al's "Investigating psoriasis awareness
among patients in Italy: validation of a questionnaire" published in the European Review for Medical and Pharmacological Sciences last 2014. Each message is 1-2 sentences long.

The primary investigator shall be the one to enroll, randomize, and send messages to the patients.

The physicians who will observe and examine the patients will be blinded to the intervention or control group assignment until the end of the study. They will also be the ones to perform disease severity scorings such as the Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), and Physicians Global Assessment (PGA) and request for Dermatology Life Quality Index
(DLQI) at every follow-up visit. Physicians assessing the patients shall be the same physician who saw the patient at baseline and at the end of 12 weeks.
Intervention code [1] 323989 0
Behaviour
Intervention code [2] 324044 0
Treatment: Other
Comparator / control treatment
No messages
Control group
Active

Outcomes
Primary outcome [1] 331952 0
Change in treatment adherence as measured by the validated self-reported
five-item Medication Adherence Report Scale (MARS-5)
Timepoint [1] 331952 0
After 12 weeks of receiving messages sent through social media
Primary outcome [2] 331953 0
Change in disease knowledge as measured by a 15-item true or false questionnaire that was adapted from Bardazzi et al's study entitled, "Investigating psoriasis awareness
among patients in Italy: validation of a questionnaire" published in the European Review for Medical and Pharmacological Sciences last 2014, with modifications done to suit the Philippine context
Timepoint [2] 331953 0
After 12 weeks of receiving messages sent through social media
Secondary outcome [1] 411720 0
Change in disease severity as measured by validated scoring tools such as PASI
Timepoint [1] 411720 0
After 12 weeks of receiving messages sent through social media
Secondary outcome [2] 411721 0
Change in patients' quality of life as measured by DLQI
Timepoint [2] 411721 0
After 12 weeks of receiving messages sent through social media
Secondary outcome [3] 411722 0
Change in treatment adherence comparing a thrice-a-week versus a once-a-week intervention of sending messages as measured by the validated self-reported
five-item Medication Adherence Report Scale (MARS-5)
Timepoint [3] 411722 0
After 12 weeks of receiving messages sent through social media
Secondary outcome [4] 411723 0
Usability and satisfaction of messages sent through social media as a composite outcome as measured by a 4-item survey questionnaire adapted from Balato et al's study entitled, "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
Timepoint [4] 411723 0
After 12 weeks of receiving messages sent through social media
Secondary outcome [5] 411939 0
Change in disease severity as measured by validated scoring tools such as BSA
Timepoint [5] 411939 0
After 12 weeks of receiving messages sent through social media
Secondary outcome [6] 411940 0
Change in disease severity as measured by validated scoring tools such as PGA
Timepoint [6] 411940 0
After 12 weeks of receiving messages sent through social media

Eligibility
Key inclusion criteria
• Diagnosed with psoriasis
• Psoriasis Area and Severity Index (PASI) between 5 and 15
• Currently receiving systemic, and/or phototherapy and/or topical treatment
• Has the ability to acquire and access medications
• Has a Facebook account
• Has access to internet
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who cannot log in to Facebook daily

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
23/05/2022
Date of last participant enrolment
Anticipated
Actual
25/01/2023
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
159
Accrual to date
Final
159
Recruitment outside Australia
Country [1] 24887 0
Philippines
State/province [1] 24887 0

Funding & Sponsors
Funding source category [1] 311804 0
Self funded/Unfunded
Name [1] 311804 0
Jennifer Lavina T. Ngo
Country [1] 311804 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] 313277 0
None
Name [1] 313277 0
Address [1] 313277 0
Country [1] 313277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311248 0
Rizal Medical Center Institutional Review Board
Ethics committee address [1] 311248 0
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Ethics committee country [1] 311248 0
Philippines
Date submitted for ethics approval [1] 311248 0
Approval date [1] 311248 0
05/04/2022
Ethics approval number [1] 311248 0

Summary
Brief summary
Background: Psoriasis is a chronic inflammatory disease with systemic immune dysregulation
associated with multiple comorbidities. The frequent relapses and difficult management arising from poor compliance to treatment and lifestyle behavior change often extends long-term treatment, severely affecting quality of life, making compliance to medication an integral part in the management of the disease.

Objectives: To evaluate the use of social media interventions in improving treatment adherence, disease knowledge, and several patient outcomes such as disease severity and quality of life.

Methods: A randomized, controlled, observer-blinded, three-arm, parallel clinical trial will be conducted among patients with psoriasis. Patients seeking face-to-face consult or via telemedicine at the Psoriasis will be recruited and invited to participate in this study. Research participants will be assigned to either control or intervention. Those assigned to intervention will be further subdivided into two; the first group will be receiving messages through Facebook thrice a week whereas the second group will be receiving messages once a week. Those belonging to the intervention group will be receiving messages for a period of twelve weeks in alternating order of reminder-education-reminder. Those assigned to the control group will receive no messages and will receive the standard treatment on their assigned days of follow-up. Research participants shall be assessed in two study visits, one at the beginning and one at the end of the twelfth week. The physicians who will observe and examine the patients will be blinded to the intervention or control group assignment until the end of the study. They will also be the ones to perform disease severity scorings (PASI, BSA, and PGA) and request for DLQI at every follow-up visit. Physicians assessing the patients shall be the same physician who saw the patient at baseline and at the end of 12 weeks. The primary investigator shall be the one to enroll, randomize, and send messages to the patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120450 0
Dr Jennifer Lavina T. Ngo
Address 120450 0
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Country 120450 0
Philippines
Phone 120450 0
+639669838551
Fax 120450 0
Email 120450 0
jenniferngo.md@gmail.com
Contact person for public queries
Name 120451 0
Dr Jennifer Lavina T. Ngo
Address 120451 0
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Country 120451 0
Philippines
Phone 120451 0
+632 88658400
Fax 120451 0
Email 120451 0
jenniferngo.md@gmail.com
Contact person for scientific queries
Name 120452 0
Dr Jennifer Lavina T. Ngo
Address 120452 0
Rizal Medical Center, Pasig Boulevard, Pasig City 1600
Country 120452 0
Philippines
Phone 120452 0
+632 88658400
Fax 120452 0
Email 120452 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)?
August 2022 to August 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?

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.