Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment
NCT ID: NCT02330250
Last Updated: 2016-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2014-07-31
2016-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Pharmaceutical Care
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.
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 control group will receive the medical care habitually provided by the hospital, and the follow-up by a non-pharmacist professional.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
FEMALE
No
Sponsors
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Hospital Universitario Pedro Ernesto
OTHER
Oswaldo Cruz Foundation
OTHER
Responsible Party
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Principal Investigators
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Jose FS Verani, PhD
Role: STUDY_CHAIR
Oswaldo Cruz Foundation
Locations
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Reumathology outpatient clinics Pedro Ernesto University Hospital
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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References
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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.
Silva C, Canhao 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.
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. Portuguese.
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.
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. doi: 10.1136/qhc.13.3.172.
Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-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.
Oliveira-Santos M, Verani JF, Camacho LA, de Andrade CA, Ferrante-Silva R, Klumb EM. Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial. Trials. 2016 Apr 2;17:181. doi: 10.1186/s13063-016-1317-1.
Related Links
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Método Dáder. Guía de Seguimiento Farmacoterapêutico
Other Identifiers
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ADELES/002
Identifier Type: -
Identifier Source: org_study_id
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