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
  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:


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

  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.
Experimental: 2
clinical algorithm
Procedure: 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.
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:

  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

  Eligibility

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 28, 2014