Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

NCT00687895 | Completed Phase 4 DMC

• 1 other identifier: HF2003
• Study Type: interventional
• Target: 3,131
• Locations: 1 country
• Sites: 1

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

Conditions

Malaria

Keywords

malaria microscopy primary health care children

Outcome Measures

Primary Outcomes (1)

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

  Day 0

Secondary Outcomes (2)

• prescriptions of antibiotics, cost of drugs

  Day 0

• health outcome of the patients

  Day 1-6, day 7

Study Arms (3)

1

EXPERIMENTAL

training in clinical algorithm plus microscopy

Procedure: Clinical algorithm and microscopy diagnosis of malaria

2

EXPERIMENTAL

clinical algorithm

Procedure: Clinical algorithm and microscopy diagnosis of malaria

3

NO INTERVENTION

Control

Interventions

Clinical algorithm and microscopy diagnosis of malaria 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.

1; 2

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• a) N/A

Sponsors & Collaborators

• Muhimbili University of Health and Allied Sciences: lead
• Karolinska Institutet: collaborator

Study Sites (1)

dispensaries/health centers in Kibaha and Bagamoyo

Coast, Coast Region, Tanzania

Location

Related Publications (2)

• 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.

  PMID: 15516269 BACKGROUND

• 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.

  PMID: 18831737 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Anders Bjorkman, MD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: July 1, 2003
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: June 2, 2008

Record last verified: 2008-05

Locations

TA (1)