Long-term improvement of psoriasis patients' adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals.
BACKGROUND
Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier to treatment success. Psoriasis patients require support, in order to improve their long-term use of topical drugs. The project aims to test whether a patient-supporting intervention delivered by dermatology nurses can reduce the severity of psoriasis, improve the use of topical drugs, and is cost-effective compared to standard procedure.


METHODS
The intervention consists of improved support delivered to patients by three experienced dermatology nurses, who will support patients on a regular basis by consultations with a focus on providing reminder systems, accountability, reinforcement, and building trust in the treatment. Each patient will be supported by the same dermatology nurse throughout the entire study period. The effect will be compared with standard procedure. The intervention will be tested in a randomized controlled trial during a 48-week period. A group of patients with moderate-to-severe psoriasis (psoriasis affecting ≥ 4% of the total body surface area) and 18-85 years of age who are prescribed topical treatment will be randomized to a non-intervention (n ≈ 57) or intervention group (n ≈ 57). Participants in both arms will be prescribed topical preparations containing corticosteroid and/or calcipotriol. The primary outcome will be a change in the severity of psoriasis, measured as reduction in the Lattice-System Physician's Global Assessment. Secondary outcomes will include changes in health-related quality of life (measured by disease specific and generic questionnaires), primary adherence (i.e., proportion of filled prescriptions), and secondary adherence by objective measure (rate of topical drug consumption (obtained by weighing medication packages) compared to estimated recommended consumption). A health economic evaluation is planned to run alongside the trial. Participants' total health costs will be estimated on the basis of health costs reported to the national health registries and costs spent on the intervention, after which a cost-utility and cost-effectiveness analysis will be carried out.


DISCUSSION
If the intervention can reduce the severity of psoriasis in a significant manner and is economically favorable compared to standard treatment, there is potential for implementing the intervention in dermatology clinics.


TRIAL REGISTRATION
Clinicaltrials.gov NCT04220554 . Registered on January 7, 2020. Study results, either positive, negative, or inconclusive, will be published on www.clinicaltrials.gov . Trial registration no. with the Danish Regional Committee on Health Research Ethics, registration no. 72613.
['Svendsen|Mathias Tiedemann|MT|http://orcid.org/0000-0002-4317-0873', 'Feldman|Steven R|SR|', 'Möller|Sören|S|', 'Kongstad|Line Planck|LP|', 'Andersen|Klaus Ejner|KE|']
D000328:Adult D006282:Health Personnel D006801:Humans D010349:Patient Compliance D004364:Pharmaceutical Preparations D011565:Psoriasis D011788:Quality of Life
Psoriasis Adherence Support Health-care professionals Randomized controlled trial (RCT)