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

NCT ID: NCT06506214

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-08

Study Completion Date

2024-10-08

Brief Summary

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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

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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.

Conditions

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Cutaneous Lupus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Questionnaires

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carle PAUL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Montpellier

Montpellier, , France

Site Status RECRUITING

APHP Hôpital Saint-Louis

Paris, , France

Site Status RECRUITING

Hôpital Tenon

Paris, , France

Site Status RECRUITING

University Hospital Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Carle PAUL, MD

Role: CONTACT

0567778120 ext. +33

Facility Contacts

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Didier BESSIS, MD

Role: primary

Jean-David BOUAZIZ, MD

Role: primary

François CHASSET, MD

Role: primary

Carle PAUL, MD

Role: primary

0567778120 ext. +33

Other Identifiers

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RC31/22/0298

Identifier Type: -

Identifier Source: org_study_id

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