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

Systemic Lupus Erythematosus Clinical Trial

— ADELES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330250
• Other study ID #: ADELES/002
• Status: Completed
• Phase: N/A
• First received: December 30, 2014
• Last updated: June 23, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Oswaldo Cruz Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Fundacao Oswaldo Cruz
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Medication Adherence
• Systemic Lupus Erythematosus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Reumathology outpatient clinics Pedro Ernesto University Hospital	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Oswaldo Cruz Foundation	Hospital Universitario Pedro Ernesto

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Barber N, Parsons J, Clifford S, Darracott R, Horne R. Patients' problems with new medication for chronic conditions. Qual Saf Health Care. 2004 Jun;13(3):172-5. — View Citation

Campolina AG, Ciconelli RM. [SF-36 and the development of new assessment tools for quality of life]. Acta Reumatol Port. 2008 Apr-Jun;33(2):127-33. Review. Portuguese. — View Citation

de Oliveira-Filho AD, Morisky DE, Neves SJ, Costa FA, de Lyra DP Jr. The 8-item Morisky Medication Adherence Scale: validation of a Brazilian-Portuguese version in hypertensive adults. Res Social Adm Pharm. 2014 May-Jun;10(3):554-61. doi: 10.1016/j.sapharm.2013.10.006. Epub 2013 Oct 26. — View Citation

Oliveira-Santos M, Verani JF, Klumb EM, Albuquerque EM. Evaluation of adherence to drug treatment in patients with systemic lupus erythematosus in Brazil. Lupus. 2011 Mar;20(3):320-9. doi: 10.1177/0961203310383736. Epub 2010 Dec 23. — View Citation

Petri M, Orbai AM, Alarcón GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sánchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473. — View Citation

Silva C, Canhão H, Barcelos A, Miranda L, Pinto P, Santos MJ. [Protocol for evaluation and monitoring of Systemic Lupus Erythematosus (PAMLES)]. Acta Reumatol Port. 2008 Apr-Jun;33(2):210-8. Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Quality of life	Quality of life measured by use of Medical Outcomes Study 36 - Item Short-Form Health Survey)	12 months	No

External Links

•   Método Dáder. Guía de Seguimiento Farmacoterapêutico