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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 July 2016 |
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Main ID: |
NCT02330250 |
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Date of registration:
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30/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment
ADELES |
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Scientific 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 |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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131 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02330250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Jose FS Verani, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oswaldo Cruz Foundation |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Medication Adherence
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Systemic Lupus Erythematosus
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Intervention(s)
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Other: Control
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Other: Pharmaceutical Care
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Primary Outcome(s)
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Medication adherence
[Time Frame: 12 months]
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Secondary Outcome(s)
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Quality of life
[Time Frame: 12 months]
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SLE disease activity
[Time Frame: 12 months]
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Secondary ID(s)
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ADELES/002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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