Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania - Full Text View

Purpose

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

Condition	Intervention	Phase
Malaria	Procedure: Clinical algorithm and microscopy diagnosis of malaria	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Fever Malaria

U.S. FDA Resources

Further study details as provided by Muhimbili University of Health and Allied Sciences:

Primary Outcome Measures:

the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

prescriptions of antibiotics, cost of drugs [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
health outcome of the patients [ Time Frame: Day 1-6, day 7 ] [ Designated as safety issue: No ]

Enrollment:	3131
Study Start Date:	July 2003
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 training in clinical algorithm plus microscopy	Procedure: Clinical algorithm and microscopy diagnosis of malaria Clinical alogarithm The content of the package included description of signs and symptoms of malaria disease history taking relevant to malaria and physical examination identification of danger signs and severe illness for referral appropriate treatment counseling patients on the use of drugs. Malaria microscopy. contents make thick blood smears from patients with fever and stain with Giemsa identify and count malaria parasites maintain the microscope and store blood slides.
Experimental: 2 clinical algorithm	Procedure: Clinical algorithm and microscopy diagnosis of malaria Clinical alogarithm The content of the package included description of signs and symptoms of malaria disease history taking relevant to malaria and physical examination identification of danger signs and severe illness for referral appropriate treatment counseling patients on the use of drugs. Malaria microscopy. contents make thick blood smears from patients with fever and stain with Giemsa identify and count malaria parasites maintain the microscope and store blood slides.
No Intervention: 3 Control

Detailed Description:

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

All children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:

below five years of age
fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
the mother/guardian or caretaker consented to participate.

Patients 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

Eligibility

Ages Eligible for Study:	6 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

below five years of age
fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
the mother/guardian or caretaker consented to participate

Exclusion Criteria:

a) N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687895

Locations

Tanzania
dispensaries/health centers in Kibaha and Bagamoyo
Coast, Tanzania

Sponsors and Collaborators

Muhimbili University of Health and Allied Sciences

Karolinska Institutet

Investigators

Study Director:

Anders Bjorkman, MD

Karolinska Institutet

More Information

Publications:

Bates I, Bekoe V, Asamoa-Adu A. Improving the accuracy of malaria-related laboratory tests in Ghana. Malar J. 2004 Nov 1;3:38.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Zull Premji, professor, Muhimbili University College of Health Sciences
ClinicalTrials.gov Identifier:	NCT00687895 History of Changes
Other Study ID Numbers:	HF2003
Study First Received:	May 28, 2008
Last Updated:	May 28, 2008
Health Authority:	Tanzania: National Institute for Medical Research

Keywords provided by Muhimbili University of Health and Allied Sciences:

malaria microscopy primary health care children

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 19, 2013