Clinical trial NCT03019926: Lupus and Observance
Official title: Lupus and Observance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus, Skin Lupus
Keywords: systemic lupus erythematosus
observance
hydroxychloroquine dosage
risk factors of non-observance
SLICC score
SLEDAI score
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 200
Sex: ALL
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: The study will is proposed to anyone aged 18 years or older with a diagnosis of systemic lupus or skin lupus for at least 6 months, ans who has been prescribed with hydroxychloroquine (Plaquenil) for at least 6 months.

Brief summary: A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.

New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.

Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.

The study primary objective is to determine risk factors for non-observance

The secondary objectives are to:

* Measure the observance rate of patients with systemic lupus in Martinique.
* Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Systemic lupus defined according to the diagnostic criteria of the American College of Rheumatology " 1997, diagnosed for at least 6 months; Or Skin Lupus
3. Consultation or hospitalization at the University Hospital of Martinique, in either services of Internal Medicine, Rheumatology or Dermatology.
4. Prescription of hydroxychloroquine (Plaquenil®) for at least 6 months
5. Affiliate or beneficiary of a social security scheme.
6. Patient not opposed to participate in the study

Exclusion Criteria:

1. Age \<18 years or patient under guardianship
2. Patient not speaking and / or not understanding French
3. No prescription and/or contraindication to hydroxychloroquine
4. Systemic lupus outbreak with neurological impairment defined by SLEDAI score by a psychosis (disruption of normal activity in relation to a severe alteration of the perception of reality. Includes: hallucinations, incoherence, impoverishment of the content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic) or brain damage (with impairment of mental functions with impaired orientation, memory or other brutal appearance and fluctuating evolution).
5. History of psychiatric disorders: personality disorders, psychoses, severe depression
6. Hospitalization with a life-threatening clinical condition that does not allow to answer questions
7. Non affiliated patient or beneficiary of a social security scheme.
8. Patient refusing to participate in the study

Primary outcomes:
measure: The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)
timeFrame: Reflects the Plaquenil intake during the 40 previous days
Secondary outcomes:
measure: Patients considered as observing and non-observing will be compared according to the activity of the disease
timeFrame: 40 days
measure: Patients considered as observing and non-observing will be compared according to number of prescribed medication
timeFrame: 40 days
measure: Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders
timeFrame: 40 days
Other outcomes:
Locations:
city: Fort-de-France
country: France
facility: CHU de Martinique
state: Martinique
Study officials:
affiliation: CHU of Martinique
name: Katlyne POLOMAT, MD
role: PRINCIPAL_INVESTIGATOR
References: