Abstract
BackgroundTopical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs. Patient support by the use of applications (apps) for smartphones is suggested to improve medical adherence.Methods/designDesign: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superiority randomized controlled trial (RCT). Participants: 134 patients 18 to 75 years of age with mild-to-moderate psoriasis, who are capable of reading English language, own a smartphone, and are candidates for the study drug calcipotriol and betamethasone dipropionate (Cal/BD) cutaneous foam once daily prn (pro re nata). Intervention: A 28-day adherence-supporting app providing compulsory daily treatment reminders that pop-up on the smartphone screen with a short alert sound. The app synchronizes through Bluetooth® to an electronic monitor (EM) attached to the medication canister. The EM contains a chip registering the amount of foam, day and time the patient use the foam dispenser. The information is displayed in a diary that shows the amount of Cal/BD cutaneous foam used and the number of applied treatment sessions. The app has an optional diary with the patient’s rating of symptoms. Non-intervention: Use of Cal/BD cutaneous foam and EM without the app. All participants are prescribed Cal/BD cutaneous foam prn for the entire study period.Primary outcome obtained in week 4: rates of adherence measured by patient report, weight of medication canisters, and number of treatment sessions measured by the EM. Secondary outcomes obtained at baseline, weeks 4, 8, and 26: Lattice System Physician’s Global Assessment (LS-PGA) and Dermatology Quality of Life Index (DLQI).DiscussionThis trial tests of whether an app can improve rates of adherence to a topical antipsoriatic drug. If the app improves rates of adherence and reduces the burden of psoriasis in a clinically significant way, the app could easily be implemented as a standard routine of care in the clinic.Trial registrationNCT02858713, registered on August 3, 2016. EudraCT number 2016–002143-42.
Highlights
Topical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs
If the app improves rates of adherence and reduces the burden of psoriasis in a clinically significant way, the app could be implemented as a standard routine of care in the clinic
The patient-support app, combined with the electronic monitor (EM) unit, has three functions: 1) to provide patients with a measurement of their consumption of medicine by synchronizing to the EM, 2) to measure the severity of their psoriasis by having the patients state their symptoms in a diary and 3) to support patients in their treatment and refills through compulsory reminder messages that once daily pop up on the smartphone screen with a short alert sound and through use of optional educational and motivational text materials in the app
Summary
To the best of our knowledge, this is the first trial of whether an app can improve rates of adherence to a topical antipsoriatic drug. Informing the participants that they are being monitored should be withheld until end of the study This is necessary since any knowledge that the participant is being monitored may influence adherence [41]. Specific ethical considerations in the study Potential beneficial effects of the use of the app: If the study can show that an app can improve adherence with. The app developed by a commercial firm: The app developed by the pharmaceutical industry can be implemented in the clinic without cost for the public health system. It is estimated that potential advantages to the use of the app (improved medical adherence) outweigh any disadvantages about using the app.
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