Anaemia Clinical Trial
Official title:
A Cluster Randomised Trial of Different Methods of Haemoglobin Measurement to Improve Recognition and Treatment of Childhood and Pregnancy-related Anaemia in a Malaria Endemic Area of North East Tanzania.
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.
Study justification In spite a number of studies describing the sensitivity and specificity
of various simple tests for diagnosing anaemia(19-21) there are no studies that have
evaluated the effectiveness of basic training of heath workers, use of diagnostic tools and
assured availability of anaemia treatments, in reducing the burden of chronic anaemia in
children and pregnant women in malaria endemic areas of Africa. The cost-effectiveness of
current diagnostic tests is not known and this information is needed to guide public health
policy.
The rates of diagnosis, treatment and referral from basic health facilities depend on a
variety of factors (treatment adherence, clinic attendance, health worker awareness, local
prevalence of anaemia etc) that are likely to vary between different areas and health
facilities. A cluster randomised study has therefore been designed to shed light on these
issues.
Design overview This is a cluster randomised open label trial of 2 different 'point of care'
diagnostic tools (Hemocue and Copack) to detect anaemia in children under the age of 5
years, each compared to a control arm that will continue current routine practice (based on
clinical judgement or ineffective colorimetric methods of measuring haemoglobin). An
inherent constraint in designing this effectiveness trial of is the absence of a measure of
haemoglobin in control dispensaries. Thus the proportion of children diagnosed with anaemia
is the primary outcome and expected rates will be derived from the rolling cross-sectional
survey.
Children who are referred to the next level of care will be tracked and basic data on the
results of investigations and treatment outcome will be recorded.
A rolling cross-sectional anaemia survey in children under the age of 5 years will be
conducted in the villages served by participating health facilities throughout the trial.
Costs of anaemia diagnosis and treatment will be assessed in each of the trial arms and the
cost-effectiveness of the intervention arms will each be compared to the control arm in
diagnosing and treating anaemia and in normalising haemoglobin levels in children with
anaemia.
Social surveys (individual interviews and focus group discussions) will be conducted to
assess the acceptability and popularity of each of the interventions and to identify
treatement-seeking behaviour for and risk factors for anaemia.
The results of the trial will be circulated locally and nationally as soon as they are
available in order to maximise the usefulness of the results to health planners and
providers in Tanzania.
An exit strategy at the end of the trial will ensure that any additional resources provided
during the trial will be maintained through to the next local health planning and resource
allocation cycle.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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