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Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
Clinical algorithm and microscopy diagnosis of malaria
Sponsored by
Muhimbili University of Health and Allied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Malaria focused on measuring malaria microscopy primary health care children

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • dispensaries/health centers in Kibaha and Bagamoyo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

training in clinical algorithm plus microscopy

clinical algorithm

Control

Outcomes

Primary Outcome Measures

the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms

Secondary Outcome Measures

prescriptions of antibiotics, cost of drugs
health outcome of the patients

Full Information

First Posted
May 28, 2008
Last Updated
May 28, 2008
Sponsor
Muhimbili University of Health and Allied Sciences
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT00687895
Brief Title
Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Muhimbili University of Health and Allied Sciences
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria microscopy primary health care children

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
training in clinical algorithm plus microscopy
Arm Title
2
Arm Type
Experimental
Arm Description
clinical algorithm
Arm Title
3
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Procedure
Intervention Name(s)
Clinical algorithm and microscopy diagnosis of malaria
Intervention Description
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.
Primary Outcome Measure Information:
Title
the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
prescriptions of antibiotics, cost of drugs
Time Frame
Day 0
Title
health outcome of the patients
Time Frame
Day 1-6, day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Bjorkman, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
dispensaries/health centers in Kibaha and Bagamoyo
City
Coast
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
15516269
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.
Results Reference
background
PubMed Identifier
18831737
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.
Results Reference
derived

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Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

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