Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

NCT ID: NCT00687895

Last Updated: 2008-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-03-31

Brief Summary

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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

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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:

1. below five years of age
2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
4. 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

Conditions

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Malaria

Keywords

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malaria microscopy primary health care children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

training in clinical algorithm plus microscopy

Group Type EXPERIMENTAL

Clinical algorithm and microscopy diagnosis of malaria

Intervention Type PROCEDURE

Clinical alogarithm

The content of the package included

1. description of signs and symptoms of malaria disease
2. history taking relevant to malaria and physical examination
3. identification of danger signs and severe illness for referral
4. appropriate treatment
5. counseling patients on the use of drugs.

Malaria microscopy. contents

1. make thick blood smears from patients with fever and stain with Giemsa
2. identify and count malaria parasites
3. maintain the microscope and store blood slides.

2

clinical algorithm

Group Type EXPERIMENTAL

Clinical algorithm and microscopy diagnosis of malaria

Intervention Type PROCEDURE

Clinical alogarithm

The content of the package included

1. description of signs and symptoms of malaria disease
2. history taking relevant to malaria and physical examination
3. identification of danger signs and severe illness for referral
4. appropriate treatment
5. counseling patients on the use of drugs.

Malaria microscopy. contents

1. make thick blood smears from patients with fever and stain with Giemsa
2. identify and count malaria parasites
3. maintain the microscope and store blood slides.

3

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clinical algorithm and microscopy diagnosis of malaria

Clinical alogarithm

The content of the package included

1. description of signs and symptoms of malaria disease
2. history taking relevant to malaria and physical examination
3. identification of danger signs and severe illness for referral
4. appropriate treatment
5. counseling patients on the use of drugs.

Malaria microscopy. contents

1. make thick blood smears from patients with fever and stain with Giemsa
2. identify and count malaria parasites
3. maintain the microscope and store blood slides.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

a) N/A
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Muhimbili University College of Health Sciences

Principal Investigators

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Anders Bjorkman, MD

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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dispensaries/health centers in Kibaha and Bagamoyo

Coast, Coast Region, Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type BACKGROUND
PMID: 15516269 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18831737 (View on PubMed)

Other Identifiers

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HF2003

Identifier Type: -

Identifier Source: org_study_id