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Systemic Lupus ErythematosusESSTIMNCT02364908

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

A study testing therapeutic education in people with Systemic Lupus Erythematosus, run by University Hospital, Lille at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
therapeutic education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
7 sitesFrance
Study dates
Dec 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • CH Hôpital Duchenne

    Boulogne-sur-Mer, 62321

  • CH Douai

    Douai, 59507

  • CH Dunkerque

    Dunkirk, 59385

  • CH du Dr Schaffner

    Lens, 62307

  • CHRU, Hôpital Huriez

    Lille

  • Victor Provo Hospital

    Roubaix, 59056

  • Valenciennes hospital

    Valenciennes, 59322

Other trials in France

About this study

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

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).

Being tested
therapeutic education
Keywords
systemic lupus erythematosus, antimalarials, therapeutic education, Coping questionnaire, MASRI questionnaire, morisky medication adherence scale, lupus Quality Of Life, internal medicine
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • therapeutic educationOther

    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.

Study groups in NCT02364908
Study groupRoleWhat they receive
Patients with Systemic LupusOtherNot described
Receives: Other: therapeutic education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.

    Measured: baseline, at 12 months

Secondary outcomes (3)

  1. hydroxychloroquinémie

    Monitoring of blood levels of hydroxychloroquinémie

    Measured: between 6 months at 12 months

  2. number of non- adherent patients

    Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ;

    Measured: at 12 months

  3. quality of life scale Coping

    scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item

    Measured: baseline, at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2015 (estimated)
  2. Study startDec 2014
  3. Primary completion30 Nov 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364908
Sponsor's protocol ID
2013_65
Other IDs
2014-A00735-42
Acronym
ESSTIM
Status last verified
Oct 2018
First submitted
10 Feb 2015
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing therapeutic education in people with Systemic Lupus Erythematosus, run by University Hospital, Lille at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment. (time frame: baseline, at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

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