Skip to main content
OpenTrials
Completed

NCT Number: NCT02330250

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Behavior Connective Tissue Diseases Health Behavior Immune System Diseases Lupus Erythematosus, Systemic Medication Adherence Patient Acceptance of Health Care Patient Compliance Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reumathology outpatient clinics Pedro Ernesto University Hospital

Rio de Janeiro, 20.551-030, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmaceutical care

Other

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 names: Pharmaceutical Services

Control

Other

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.

Primary outcomes

  1. Medication adherence

    Time frame: 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 outcomes

  1. SLE disease activity

    Time frame: 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)

  2. Quality of life

    Time frame: 12 months

    Quality of life measured by use of Medical Outcomes Study 36 - Item Short-Form Health Survey)

Sponsors and collaborators

Lead sponsor

Oswaldo Cruz Foundation

Other

Collaborators

  • Hospital Universitario Pedro Ernesto

Registry information

Official study title

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

Acronym: ADELES

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2015
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.