NCT06161363

Brief Summary

The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them. The investigators want to use an already validated existing questionnaire in English, the Morisky Medication Adherence Scale 8 (MMAS 8). These results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

November 29, 2023

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non-compliance with hydroxychloroquine treatment

    to describe the non-compliance with hydroxychloroquine treatment with the Morisky Medication Adherence Scale

    Day 0

Study Arms (1)

The Morisky Medication Adherence Scale (MMAS-8)

The Morisky Medication Adherence Scale completed by the patients

Other: The Morisky Medication Adherence Scale

Interventions

The Morisky Medication Adherence Scale will be completed bu the patients

The Morisky Medication Adherence Scale (MMAS-8)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with systemic lupus erythematosus

You may qualify if:

  • Age \>18 years
  • Patient with systemic lupus erythematosus
  • Treatment with PLAQUENIL for \> 6 months with dosage of hydroxychloroquinemia planned during the consultation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse Hospital

Toulouse, France

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

November 27, 2023

Primary Completion

November 16, 2024

Study Completion

December 16, 2024

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations