ESSTIM: Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT02364908

Collaborator

Région Nord-Pas de Calais, France (Other)

158

Enrollment

Locations

Arm

Actual Duration (Months)

22.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Other: therapeutic education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Nov 30, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with Systemic Lupus	Other: therapeutic education This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.

Arm

Intervention/Treatment

Other: Patients with Systemic Lupus

Other: therapeutic education

This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.

Outcome Measures

Primary Outcome Measures

measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment. [baseline, at 12 months]

Secondary Outcome Measures

hydroxychloroquinémie [between 6 months at 12 months]
Monitoring of blood levels of hydroxychloroquinémie
number of non- adherent patients [at 12 months]
Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;
quality of life scale Coping [baseline, at 12 months]
scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with a systemic lupus with ACR criteria (at least 4 criterias)
patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

Exclusion Criteria:

patients who refuse to sign the informed consent
patients who are under guardianship

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Hôpital Duchenne	Boulogne sur Mer	France	62321
2	CH Douai	Douai	France	59507
3	CH Dunkerque	Dunkerque	France	59385
4	CH du Dr Schaffner	Lens	France	62307
5	CHRU, Hôpital Huriez	Lille	France
6	Victor Provo Hospital	Roubaix	France	59056
7	Valenciennes hospital	Valenciennes	France	59322