Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment

Not Applicable

Completed

• Conditions: Medication Adherence; Systemic Lupus Erythematosus
• Interventions: Other: Pharmaceutical Care; Other: Control

• Registration Number: NCT02330250
• Lead Sponsor: Oswaldo Cruz Foundation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-12-30
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-01
• Primary Completion: 2016-02
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

Not provided

Exclusion Criteria

• Current renal replacement therapy.
• Renal transplantation.
• Ongoing pulse therapy with cyclophosphamide and/or methylprednisolone.
• Aid by caregiver.
• Any psychiatric illness.
• Inability to understand the questions of the questionnaire.
• Patients'unwillingness to sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmaceutical Care	Pharmaceutical Care	The patients will receive guidance from a pharmacist based on the Dader Method for Pharmaceutical Care, in addition to the medical care habitually delivered by the hospital.
Control	Control	The control group will receive the medical care habitually provided by the hospital, and the follow-up by a non-pharmacist professional.

Primary Outcome Measures

Name	Time	Method
Medication adherence	12 months	Medication adherence will be measured by use of the eight-item Morisk Medication Adherence Scale (MMAS) translated and validated to brazilian portuguese

Secondary Outcome Measures

Name	Time	Method
SLE disease activity	12 months	SLE disease activity measured by use of Safety of Estrogens in Systemic Lupus National SLE Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Quality of life	12 months	Quality of life measured by use of Medical Outcomes Study 36 - Item Short-Form Health Survey)

Trial Locations

Locations (1)

Reumathology outpatient clinics Pedro Ernesto University Hospital; 🇧🇷 Rio de Janeiro, Brazil