A Trial of 2 'Point of Care' Diagnostic Methods to Improve Detection and Treatment of Anaemia in African Children

NCT00439595 | Completed

• 1 other identifier: EARS-Handeni
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

A high proportion of children under the age of 5 years and pregnant women in Tanzania is anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are often non-specific or absent and clinical judgement is generally insensitive in estimating Hb levels, especially in infants who are assessed by basic grade health staff. Thus while treatment for the common causes of anaemia is available, many cases are not treated due to difficulties in recognising anaemia. New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical diagnosis but no studies have demonstrated their effectiveness in increasing case-detection and treatment of anaemic patients at the first level of healthcare. In addition, the costs of their use in relation to any increase in numbers of cases treated are not known and this knowledge is needed to guide public health decisions. Two methods of measuring anaemia are currently suitable for use at the first level of care; Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to compare the effectiveness in basic health facilities of these 2 simple diagnostic tools compared to control dispensaries (current practice) in increasing rates of detection and treatment of anaemia in children under the age of 5 years and pregnant women over the course of 1 year in a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE Tanzania.

Conditions

Anaemia

Keywords

Anaemia; Diagnosis; Primary; Care; Treatment

Outcome Measures

Primary Outcomes (1)

• The proportion of clinic attenders under the age of 5 years who are diagnosed with anaemia (adjusted for anaemia in the community)

  1 year

Secondary Outcomes (6)

• Proportion of anaemic children and pregnant women treated for anaemia

  1 year

• Prevalence of anaemia in study communities by age and season

  1 year

• Proportion of clinic attenders referred to the district hospital with Hb> and <8g/dl.

  1 year

• Effectiveness of current MOH anaemia treatment regimens.

  1 year

• Acceptability of HBCS and Hemocue and attitudes to anaemia diagnosis among caretakers and healthworkers

  1 year

Study Arms (3)

1

EXPERIMENTAL

Hemocue 210 meter

Device: Hemocue 210 meter

2

EXPERIMENTAL

Copack HBCS

Device: Copack HBCS

3

NO INTERVENTION

Control

Interventions

Hemocue 210 meter DEVICE

Diagnostic device

1

Copack HBCS DEVICE

2

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age under 5 years
• Pregnancy
• Suspected anaemia

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (1)

Handeni District Health Facilities

Tanga, Tanga, Tanzania

Location

MeSH Terms

Conditions

Anemia; Disease

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hugh Reyburn, MD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 27, 2010

Record last verified: 2010-05

Locations

TA (1)