ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Psoriasis

Condition category

Condition code

Skin

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Absence of text message

Control group

Active

Outcomes

Primary outcome [1]

Change in treatment adherence as measured by the validated Medication Adherence Questionnaire (MAQ)

Timepoint [1]