Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment (ADELES)

Oswaldo Cruz Foundation

Status: Completed

Conditions: Medication Adherence; Systemic Lupus Erythematosus

Treatments: Other: Pharmaceutical Care; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02330250

ADELES/002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SLE diagnosis according to the 2012 SLICC (Systemic Lupus International Collaborating Clinics Group) SLE classification criteria.
• Treatment with corticosteroids and antimalarials.
• History of biopsy-proven lupus nephritis classes III, IV, or V (2003 International Society of Nephrology / Renal Pathology Society) or nephritic/nephrotic lupus flare not undergone to kidney biopsy.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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131 participants in 2 patient groups

Pharmaceutical Care

Experimental group

Description:

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.

Treatment:

Other: Pharmaceutical Care

Control

Sham Comparator group

Description:

The control group will receive the medical care habitually provided by the hospital, and the follow-up by a non-pharmacist professional.

Treatment:

Other: Control