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

NCT06506214 | Recruiting

• 1 other identifier: RC31/22/0298
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 4

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.

Conditions

Cutaneous Lupus

Outcome Measures

Primary Outcomes (1)

• Evaluation of adherence to treatment of patients with cutaneous lupus.

  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

Study Arms (1)

Study group

Other: Questionnaires

Interventions

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)

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (4)

University Hospital Montpellier

Montpellier, 34090, France

RECRUITING

APHP Hôpital Saint-Louis

Paris, 75010, France

RECRUITING

Hôpital Tenon

Paris, 75020, France

RECRUITING

University Hospital Toulouse

Toulouse, 31400, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carle PAUL, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carle PAUL, MD

CONTACT

0567778120; paul.c@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: October 8, 2022
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)