AnaemiaEARSNCT00439595
A Trial of 2 'Point of Care' Diagnostic Methods to Improve Detection and Treatment of Anaemia in African Children
A study testing Hemocue 210 meter and Copack HBCS in people with Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Anaemia
- What is being tested?
- Hemocue 210 meter and Copack HBCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age under 5 years
- Pregnancy
- Suspected anaemia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Anaemia
- Being tested
- Hemocue 210 meter, Copack HBCS
- Keywords
- Anaemia, Diagnosis, Primary, Care, Treatment
- Medical subject headings
- Anemia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemocue 210 meterDevice
Diagnostic device
Copack HBCSDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hemocue 210 meter Receives: Device: Hemocue 210 meter |
| 2 | Experimental | Copack HBCS Receives: Device: Copack HBCS |
| 3 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clinic attenders under the age of 5 years who are diagnosed with anaemia (adjusted for anaemia in the community)
Measured: 1 year
Secondary outcomes (6)
Proportion of anaemic children and pregnant women treated for anaemia
Measured: 1 year
Prevalence of anaemia in study communities by age and season
Measured: 1 year
Proportion of clinic attenders referred to the district hospital with Hb> and <8g/dl.
Measured: 1 year
Effectiveness of current MOH anaemia treatment regimens.
Measured: 1 year
Acceptability of HBCS and Hemocue and attitudes to anaemia diagnosis among caretakers and healthworkers
Measured: 1 year
Cost effectiveness of HBC or Hemocue compared to current practice in increasing anaemia diagnosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Investigators
- Hugh Reyburn, MD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439595
- Sponsor's protocol ID
- EARS-Handeni
- Acronym
- EARS
- Status last verified
- May 2010
- First submitted
- 22 Feb 2007
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00439595
- Acronym / sponsor ID
- EARS / EARS-Handeni
- Conditions
- Anaemia
- Keywords
- Anaemia, Diagnosis, Primary, Care, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Study start
- Feb 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Hemocue 210 meterHemocue 210 meter |
| 2 | Experimental | Device: Copack HBCSCopack HBCS |
| 3 | No intervention | –Control |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age under 5 years
- Pregnancy
- Suspected anaemia
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemocue 210 meterDiagnostic device | Device | 1 |
| Copack HBCS | Device | 2 |
Primary outcome
The proportion of clinic attenders under the age of 5 years who are diagnosed with anaemia (adjusted for anaemia in the community)
Time frame: 1 year
6 secondary outcomes
Proportion of anaemic children and pregnant women treated for anaemia
Time frame: 1 year
Prevalence of anaemia in study communities by age and season
Time frame: 1 year
Proportion of clinic attenders referred to the district hospital with Hb> and <8g/dl.
Time frame: 1 year
Effectiveness of current MOH anaemia treatment regimens.
Time frame: 1 year
Acceptability of HBCS and Hemocue and attitudes to anaemia diagnosis among caretakers and healthworkers
Time frame: 1 year
Cost effectiveness of HBC or Hemocue compared to current practice in increasing anaemia diagnosis.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Reyburn, MD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemocue 210 meter and Copack HBCS in people with Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of clinic attenders under the age of 5 years who are diagnosed with anaemia (adjusted for anaemia in the community) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.