Abstract
BackgroundPsoriasis 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.MethodsThe 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.DiscussionIf 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 registrationClinicaltrials.govNCT04220554. 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.
Highlights
Background and rationale {6a} Psoriasis is a chronic inflammatory skin disease affecting 2–4% of the adult Western population [1]
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
The sample size was calculated based on data from a previous project obtaining Lattice System Physician’s Global Assessment (LS-PGA) data from 134 patients randomized to intervention or non-intervention [8], where an over 20% LS-PGA improvement in favor of the adherencesupport intervention was observed between nonintervention and intervention group
Summary
Background and rationale {6a} Psoriasis is a chronic inflammatory skin disease affecting 2–4% of the adult Western population [1]. It is associated with many comorbidities, negatively affects quality of life [2], and is a socio-economic burden for patients and society [3]. Topical drugs are the recommended first-line treatment for mild-to-moderate psoriasis, but patient’s adherence to treatment is low, which is a barrier to treatment success [4]. 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
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