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NCT Number: NCT06506214

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Montpellier, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ADlupus

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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