NCT02330250

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

Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment in Rio de Janeiro: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Oswaldo Cruz Foundation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus
• Medication Adherence

Interventions

Type	Name	Description
OTHER	Pharmaceutical Care	The patients assigned for the intervention group will receive guidance from a pharmacist ("pharmaceutical consultation") in addition to the medical care habitually delivered by the hospital. The pharmacist will review the drug therapy, identifying current and potential problems related to the drug prescription, making a systematic assessment of the need, effectiveness and safety of all medications and their adequacy to the patient's life routine. A care plan will then be designed along with the patient that may include interventions and/or referral to other practitioners.
OTHER	Control	The patients assigned to the control group will receive the medical care habitually provided by the hospital and will be attended by a non-pharmacist professional, who will provide hygiene/nutritional counseling and risk reduction, such as smoking cessation advice; use of estrogen-based contraceptive drugs; exposure to sunlight, proper use of sunscreen and clothes; nutritional guidance on the intake of low saturated-fat food. As usual, information about the use of medication will be provided by the attending physician.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2015-01-01
• Last updated: 2016-06-24

Locations

1 site across 1 country: Brazil