Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial

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.Electronic supplementary materialThe online version of this article (10.1186/s12895-018-0071-3) contains supplementary material, which is available to authorized users.

A systematic review of factors influencing treatment adherence in chronic inflammatory skin disease – strategies for optimizing treatment outcome

“…Reminder programs using e‐mails, phone calls, text messages or smartphone applications can be helpful to counteract patients’ forgetfulness . The success rate of these programs in improving adherence is, however, inconsistent according to the literature, and depends on patients’ character and personality …”

“…97 The success rate of these programs in improving adherence is, however, inconsistent according to the literature, and depends on patients' character and personality. 16,56,98,99 Simplifying treatment regimes and reducing pill burden are easy methods to enhance treatment adherence. Once-daily regimes with combined pharmacological agents are preferable, since they are more manageable for the patient.…”

A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial

“…A 6‐month investigator‐initiated single‐site, parallel‐group, phase‐IV superiority block randomized controlled trial (RCT) with an allocation ratio of 1 : 1 was conducted according to the principles expressed in the Declaration of Helsinki as revised in 1983, the International Conference on Harmonisation Good Clinical Practice Guideline E6 (R2), and Danish national laws (clinicaltrials.gov registration NCT02858713). The protocol was approved by the Regional Ethics Committees on Health Research Ethics for Southern Denmark and the Danish Medicines Agency (EudraCT 2016‐002143‐42) . The study was conducted between 9 January 2017 and 29 August 2017 at an outpatient clinic for dermatology at Odense University Hospital.…”

“…The protocol was approved by the Regional Ethics Committees on Health Research Ethics for Southern Denmark and the Danish Medicines Agency (EudraCT 2016-002143-42). 22 The study was conducted between 9 January 2017 and 29 August 2017 at an outpatient clinic for dermatology at Odense University Hospital. Written informed consent was obtained from all patients at inclusion and prior to randomization.…”

EULAR points to consider for the development, evaluation and implementation of mobile health applications aiding self-management in people living with rheumatic and musculoskeletal diseases

“…For example, a previous survey among people living with type 1 diabetes mellitus found that 40% of respondents reported being aware of self-management apps 12. Alongside the value of apps in patient self-empowerment, they can also facilitate patient communication with health professionals,13 improve treatment adherence,14 provide condition-specific education and enable remote condition monitoring 15 16…”