N/A
N=103
Improvement of Psoriasis Patients' Adherence to Topical Drugs
Psoriasis Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT04220554 ↗Enrolled (actual)
103
Serious AEs
31.1%
Results posted
Jan 2024
Primary outcome: Primary: Severity of Psoriasis — 2.68; 1.84 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Improved support by health-care professionals (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Odense University Hospital
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Psoriasis |
2.68; 1.84 | — |
| SECONDARY Secondary Adherence |
106; 72 | — |
| SECONDARY Quality of Life (QOL) |
6.88; 1.55 | — |
Summary
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 for treatment success. There is a need for improved patient support for psoriasis patients, which is suggested to improve long-term use of topical drugs.
The project aims to test whether a patient-supporting intervention delivered by healthcare professionals can improve the use of topical drugs. The intervention design is based on experiences with previous adherence-improving studies consisting of digital support by conducting a systematic literature search and holding focus groups with patients as well as healthcare professionals. The intervention consists of shared decision-making with patients, nurses and doctors, frequent consultations, easy access to healthcare professionals through video or in-office consultations and holding patients accountable for taking the medication.
The intervention will be tested in a randomized controlled trial: during a 48 week period, a group of patients (18-85 years of age) diagnosed with mild-to-moderate psoriasis and treated with topical drugs will be randomized to an intervention (n=40) or non-intervention group (n=40). The primary outcome will be severity of psoriasis and secondary outcomes primary adherence (i.e., rate of filled prescriptions) and quality of life.
If the intervention can reduce the severity of psoriasis in a significant manner, there is a potential for a national implementation of the intervention.
Eligibility Criteria
Inclusion Criteria: Legally competent patients with milder-to-moderate psoriasis
Exclusion Criteria: Incapable patients not diagnosed with psoriasis
Data sourced from ClinicalTrials.gov (NCT04220554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.