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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Systemic Lupus Erythematosus, Medication Adherence

Intervention / Treatment
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* Other: Pharmaceutical Care
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical Care<br>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. | Other: Pharmaceutical Care<br>* 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.<br>* Other names: Pharmaceutical Services;|
| Sham Comparator: Control<br>The control group will receive the medical care habitually provided by the hospital, and the follow-up by a non-pharmacist professional. | Other: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Medication adherence will be measured by use of the eight-item Morisk Medication Adherence Scale (MMAS) translated and validated to brazilian portuguese | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Lupus Erythematosus, Pharmaceutical care, Pharmaceutical services, Medication adherence