Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

This study has been completed.

Sponsor:

Collaborator:

Karolinska Institutet

Information provided by:

Muhimbili University of Health and Allied Sciences

ClinicalTrials.gov Identifier:

NCT00687895

First received: May 28, 2008

Last updated: NA

Last verified: May 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

May 28, 2008

Last Updated Date

May 28, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

Official Title ^ICMJE

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

Brief Summary

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Malaria

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1
training in clinical algorithm plus microscopy

Intervention: Procedure: Clinical algorithm and microscopy diagnosis of malaria
Experimental: 2
clinical algorithm

Intervention: Procedure: Clinical algorithm and microscopy diagnosis of malaria
No Intervention: 3
Control

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3131

Completion Date

March 2004

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 59 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Tanzania

Administrative Information

NCT Number ^ICMJE

NCT00687895

Other Study ID Numbers ^ICMJE

HF2003

Has Data Monitoring Committee

Yes

Responsible Party

Zull Premji, professor, Muhimbili University College of Health Sciences

Study Sponsor ^ICMJE

Muhimbili University of Health and Allied Sciences

Collaborators ^ICMJE

Karolinska Institutet

Investigators ^ICMJE

Study Director:

Anders Bjorkman, MD

Karolinska Institutet

Information Provided By

Muhimbili University of Health and Allied Sciences

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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