Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-30 @ 7:28 PM
Study NCT ID:
NCT00687895
Status:
COMPLETED
Last Update Posted:
2008-06-02
First Post:
2008-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-28', 'studyFirstSubmitDate': '2008-05-28', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'prescriptions of antibiotics, cost of drugs', 'timeFrame': 'Day 0'}, {'measure': 'health outcome of the patients', 'timeFrame': 'Day 1-6, day 7'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['malaria microscopy primary health care children'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '15516269', 'type': 'BACKGROUND', 'citation': 'Bates I, Bekoe V, Asamoa-Adu A. Improving the accuracy of malaria-related laboratory tests in Ghana. Malar J. 2004 Nov 1;3:38. doi: 10.1186/1475-2875-3-38.'}, {'pmid': '18831737', 'type': 'DERIVED', 'citation': 'Ngasala B, Mubi M, Warsame M, Petzold MG, Massele AY, Gustafsson LL, Tomson G, Premji Z, Bjorkman A. Impact of training in clinical and microscopy diagnosis of childhood malaria on antimalarial drug prescription and health outcome at primary health care level in Tanzania: a randomized controlled trial. Malar J. 2008 Oct 2;7:199. doi: 10.1186/1475-2875-7-199.'}]}, 'descriptionModule': {'briefSummary': 'General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs', 'detailedDescription': 'PHC facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from Muhimbili University College of Health Sciences (MUCHS), Dar es Salaam\n\nAll children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:\n\n1. below five years of age\n2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days\n3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur\n4. the mother/guardian or caretaker consented to participate.\n\nPatients with severe disease and/or general danger signs requiring inpatient care according to the IMCI guidelines were admitted or referred to the health centers or the district hospitals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. below five years of age\n2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days\n3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur\n4. the mother/guardian or caretaker consented to participate\n\nExclusion Criteria:\n\na) N/A'}, 'identificationModule': {'nctId': 'NCT00687895', 'briefTitle': 'Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Muhimbili University of Health and Allied Sciences'}, 'officialTitle': 'Quality Malaria Case Management In Under- Fives In Primary Health Care (Phc) Institutions In Bagamoyo And Kibaha Districts Of Coastal Tanzania:a Multicomponent Controlled Intervention Study', 'orgStudyIdInfo': {'id': 'HF2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'training in clinical algorithm plus microscopy', 'interventionNames': ['Procedure: Clinical algorithm and microscopy diagnosis of malaria']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'clinical algorithm', 'interventionNames': ['Procedure: Clinical algorithm and microscopy diagnosis of malaria']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'Control'}], 'interventions': [{'name': 'Clinical algorithm and microscopy diagnosis of malaria', 'type': 'PROCEDURE', 'description': 'Clinical alogarithm\n\nThe content of the package included\n\n1. description of signs and symptoms of malaria disease\n2. history taking relevant to malaria and physical examination\n3. identification of danger signs and severe illness for referral\n4. appropriate treatment\n5. counseling patients on the use of drugs.\n\nMalaria microscopy. contents\n\n1. make thick blood smears from patients with fever and stain with Giemsa\n2. identify and count malaria parasites\n3. maintain the microscope and store blood slides.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coast', 'state': 'Coast Region', 'country': 'Tanzania', 'facility': 'dispensaries/health centers in Kibaha and Bagamoyo'}], 'overallOfficials': [{'name': 'Anders Bjorkman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Zull Premji, professor', 'oldOrganization': 'Muhimbili University College of Health Sciences'}}}}