Clinical trial NCT00687895: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: malaria microscopy primary health care children
Lead sponsor: Muhimbili University of Health and Allied Sciences
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2008-06-02
Enrollment: 3131
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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 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

Primary outcomes:
measure: the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms
timeFrame: Day 0
Secondary outcomes:
measure: prescriptions of antibiotics, cost of drugs
timeFrame: Day 0
measure: health outcome of the patients
timeFrame: Day 1-6, day 7
Other outcomes:
Locations:
city: Coast
country: Tanzania
facility: dispensaries/health centers in Kibaha and Bagamoyo
Study officials:
affiliation: Karolinska Institutet
name: Anders Bjorkman, MD
role: STUDY_DIRECTOR
References:
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.
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.