Systemic Lupus Erythematosus Clinical Trial
Official title:
Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment in Rio de Janeiro: a Randomized Clinical Trial
This project aims to improve adherence rate through pharmaceutical care in patients with systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve the quality of life of these patients.
Adherence to treatment is a primary determinant for the effectiveness of health care.
Non-compliance may lead to therapeutic failure, make more difficult and complex the
management of chronic diseases or cause death. The effectiveness of interventions on
adherence has an important impact in the health of the population. Systemic lupus
erythematosus (SLE) is an autoimmune disease with high proportion of hospital admissions and
deaths and high cost of treatment. The prevalence of adherence in this group of patients in
Brazil is very low (31.7%) and the drug treatment is complex. Our aim is to assess the
effectiveness of Pharmaceutical Care in the adherence of drug treatment by SLE patients
attended in a Rheumatology outpatient clinic in Rio de Janeiro, Brazil.
Randomized clinical trial (pragmatic trial), in which 120 adult patients with confirmed SLE
diagnosis will be followed for 12 months, and randomized in two groups: the intervention
group (attended by a pharmacist according to the Dader Method for Pharmaceutical Care), and
the control group (attended by a non-pharmacist professional with counseling on
hygiene/nutrition and reduction of risks in lupus therapy). The main outcome will be
adherence to drug therapy and secondary outcomes the improvement of the medical condition
and the quality of life of the patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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