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
About this trial
This is an interventional health services research trial for Malaria focused on measuring malaria microscopy primary health care children
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
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
NCT ID
NCT00687895
First Posted
May 28, 2008
Last Updated
May 28, 2008
Sponsor
Muhimbili University of Health and Allied Sciences
Collaborators
Karolinska Institutet
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
Learn more about this trial
Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania
We'll reach out to this number within 24 hrs