Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus (ADlupus)

May 7, 2026 updated by: University Hospital, Toulouse

Cross-sectional Multicenter Study Aimed at Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • University hospital Montpellier
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75010
        • APHP Hôpital Saint-Louis
      • Toulouse, France, 31400
        • University Hospital toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Other: Questionnaires

Responses to questionnaires:

  • Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
  • Medical Adherence Self-Report Inventory (MASRI)
  • Morisky Medication Adherence Scale (MMAS4)
  • Visual analog scale (VAS) on the perception of disease control
  • Belief on Medicine Questionnaire (BMQ)
  • Care patient Feedback measure
  • Hospital Anxiety and Depression Scale (HAD)
  • Dermatology Life Quality Index (DLQI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of adherence to treatment of patients with cutaneous lupus.
Time Frame: Inclusion day
Adherence is defined by a VAS greater than or equal to 80% on the Visual Analog Scale of the MASRI (Medical Adherence Self-Report Inventory) questionnaire.
Inclusion day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Carle PAUL, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2022

Primary Completion (Actual)

January 19, 2026

Study Completion (Actual)

January 19, 2026

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/22/0298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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