Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-29 @ 3:59 PM
Study NCT ID:
NCT02330250
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2014-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2014-12-30', 'studyFirstSubmitQcDate': '2014-12-31', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence', 'timeFrame': '12 months', 'description': 'Medication adherence will be measured by use of the eight-item Morisk Medication Adherence Scale (MMAS) translated and validated to brazilian portuguese'}], 'secondaryOutcomes': [{'measure': 'SLE disease activity', 'timeFrame': '12 months', 'description': 'SLE disease activity measured by use of Safety of Estrogens in Systemic Lupus National SLE Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)'}, {'measure': 'Quality of life', 'timeFrame': '12 months', 'description': 'Quality of life measured by use of Medical Outcomes Study 36 - Item Short-Form Health Survey)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Pharmaceutical care', 'Pharmaceutical services', 'Medication adherence'], 'conditions': ['Systemic Lupus Erythematosus', 'Medication Adherence']}, 'referencesModule': {'references': [{'pmid': '24268603', 'type': 'BACKGROUND', '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.'}, {'pmid': '18604187', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18604180', 'type': 'BACKGROUND', '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. Portuguese.'}, {'pmid': '21183558', 'type': 'BACKGROUND', '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.'}, {'pmid': '15175485', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '22553077', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27038611', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.pharmanet.com.br/atencao/metododader.pdf', 'label': 'Método Dáder. Guía de Seguimiento Farmacoterapêutico'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nRandomized 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* SLE diagnosis according to the 2012 SLICC (Systemic Lupus International Collaborating Clinics Group) SLE classification criteria.\n* Treatment with corticosteroids and antimalarials.\n* 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.\n\nExclusion Criteria:\n\n* Current renal replacement therapy.\n* Renal transplantation.\n* Ongoing pulse therapy with cyclophosphamide and/or methylprednisolone.\n* Aid by caregiver.\n* Any psychiatric illness.\n* Inability to understand the questions of the questionnaire.\n* Patients'unwillingness to sign the informed consent."}, 'identificationModule': {'nctId': 'NCT02330250', 'acronym': 'ADELES', 'briefTitle': 'Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Oswaldo Cruz Foundation'}, 'officialTitle': 'Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment in Rio de Janeiro: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ADELES/002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmaceutical Care', 'description': '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.', 'interventionNames': ['Other: Pharmaceutical Care']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'The control group will receive the medical care habitually provided by the hospital, and the follow-up by a non-pharmacist professional.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Pharmaceutical Care', 'type': 'OTHER', 'otherNames': ['Pharmaceutical Services'], 'description': '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.\n\nThe 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.', 'armGroupLabels': ['Pharmaceutical Care']}, {'name': 'Control', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20.551-030', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Reumathology outpatient clinics Pedro Ernesto University Hospital', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Jose FS Verani, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oswaldo Cruz Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oswaldo Cruz Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Pedro Ernesto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}