Clinical trial NCT06506214: Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus
Official title: Cross-sectional Multicenter Study Aimed at Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Lupus
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 233
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cutaneous lupus (pure cutaneous or subacute) diagnosed by a dermatologist and under local and/or systemic treatment for cutaneous lupus.

Brief summary: This multicenter study aims to evaluate treatment adherence and satisfaction of patients with cutaneous lupus, influenced by perception of the disease, fear of side effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or higher on the Medical Adherence Self-Report Inventory scale.

Detailed description: This multicenter, cross-sectional study aims to characterize adherence to treatment and satisfaction of patients with cutaneous lupus. Non-adherence to treatment is a major problem, influenced by perception of the disease, fear of adverse effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or more on the visual analog scale of the Medical Adherence Self-Report Inventory questionnaire.

The study is descriptive, multicenter and cross-sectional. Participants will be adult patients suffering from cutaneous lupus, diagnosed by a dermatologist and under treatment, able to complete questionnaires. Patients with systemic lupus, cognitive or psychiatric disorders will be excluded from the study.

The inclusion period is two years, with 30 minutes of follow-up per participant. The study will provide a better understanding of the feelings of patients with cutaneous lupus and the factors limiting their adherence to treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with cutaneous lupus (pure cutaneous or subacute) diagnosed by a dermatologist and under local and/or systemic treatment for cutaneous lupus
* No opposition to participation
* Patient able to complete the questionnaires
* Adult patient

Exclusion Criteria:

* Systemic lupus with multiple visceral involvement
* Cognitive or psychiatric disorders preventing the smooth running of the study
* Pregnant woman
* Patient under guardianship/curatorship or safeguard of justice

Primary outcomes:
measure: Evaluation of adherence to treatment of patients with cutaneous lupus.
timeFrame: Inclusion day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Montpellier
city: Paris
country: France
facility: APHP Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Tenon
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Carle PAUL, MD
role: PRINCIPAL_INVESTIGATOR
References: