MalnutritionNCT02833740
Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition
A study testing Click-MUAC prototype & regular MUAC tape in people with Malnutrition, run by Action Contre la Faim at 1 site in Kenya.
Trial summary
The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of a set of three simplified mid-upper arm circumference classification devices ("Click-MUAC") for use by mothers and caregivers to screen for acute malnutrition in young children. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Click-MUAC prototype & regular MUAC tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2016to Apr 2017
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child 6-59 months with MUAC < 115 mm presenting at health facility for treatment of acute malnutrition or identified at paediatric outpatient clinic.
- Child 6-59 months with MUAC < 115 mm currently enrolled in IMAM programme
- Child 6-59 months with MUAC between 115 mm and 125 mm presenting at health facility for treatment of acute malnutrition or identified at paediatric outpatient clinic.
- Child 6-59 months with MUAC between 115 mm and 125 mm currently enrolled in IMAM programme.
- Child 6-59 months with MUAC ≥ 125 mm identified at paediatric outpatient clinic.
- AND informed consent of mother / caregiver
Who cannot join
- Child < 6 months or >59 months.
- Child with physical handicap preventing mid-upper arm circumference measurement.
- Child requiring immediate and urgent medical attention for medical complications.
- Child with mid-upper arm skin lesions (e.g. scabies, impetigo, ringworm).
- Bilateral pitting oedema.
- Caregiver consent not given.
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Isiolo County Health Facilities implementing integrated management of acute malnutrition (IMAM)
Isiolo, Isiolo County
James Njiru, +254 706519615, nutiycn.ke@acf-international.org
About this study
Official title: Field Testing of a Set of Simplified Mid-upper Arm Circumference Classification Devices ("Click-MUAC") for Use by Mothers and Caregivers to Screen for Acute Malnutrition in Young Children at Community Level, in Isiolo County, Kenya
The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of a set of three simplified mid-upper arm circumference classification devices ("Click-MUAC") for use by mothers and caregivers to screen for acute malnutrition in young children. The study will be conducted in Isiolo County, Kenya. The study builds on the recent approach of training mothers to screen for acute malnutrition in their own children (mother MUAC approach).
The primary aim of the study is to describe and compare the performance of a set of three prototype Click-MUAC devices against a gold standard of classification, in terms of measures of agreement (sensitivity, specificity, accuracy, Cohen's Kappa, Youden's J) for the classification (diagnosis) of acute malnutrition. A secondary aim of the study is to determine the difference in agreement with the gold standard classification amongst mothers/caregivers using a Click-MUAC prototype versus mothers/caregivers using a regular MUAC tape. The hypothesis of the study is that at least one of the Click-MUAC prototypes is equal to the gold standard of classification in terms of measures of agreement for the classification of acute malnutrition. A secondary hypothesis of the study is that agreement with the gold standard classification is better amongst mothers/caregivers using a Click-MUAC prototype compared to mothers/caregivers using a regular MUAC tape. The outcomes of the study will be used to decide on whether production of a Click-MUAC device is desirable and, if this is the case, to select a design based on the performance of the prototype devices and the stated preferences of intended users.
Read the detailed description
The study will be a non-randomised, non-blinded, clinical diagnostic trial describing and comparing performance that will be conducted in two phases: (i) calibration of the devices, (ii) testing of Click-MUAC prototypes against "gold standard" classification.
The study will take place at designated health facilities within Isiolo County that already have an IMAM programme running. The investigators expect that the health facilities with the highest number of acute malnutrition admissions will be selected as study sites in order to be able to test the prototypes on a large number of attending Severe Acute Malnutrition (SAM)/Moderate Acute Malnutrition (MAM) children.
The first phase of work will concentrate on the calibration of Click-MUAC prototypes. The performance of the Click-MUAC prototypes with regard to accuracy of classification will be assessed in children with a measured MUAC at or close to the 115 mm and 125 mm case-defining thresholds. This phase of work is required as prior testing of the Click-MUAC prototypes will only have been performed on semi-rigid testing tubes.
The second phase of work will test the Click-MUAC prototypes. Three sets of measurements/classifications will be taken during the Click-MUAC testing trial: (i) Mother/caregiver MUAC classification performed by the mother/primary caregiver on their own child, using each of the three Click-MUAC prototypes and a regular MUAC tape; (ii) IMAM staff MUAC classification performed by the Integrated Management of Acute malnutrition (IMAM) staff on the same child, using each of the three Click-MUAC prototypes and a regular MUAC tape; (iii) Gold standard MUAC measurement performed by the study coordinator and/or data collection team members trained in the measurement of MUAC and selected for their accuracy (i.e. against the study supervisor) and precision of measurement, following a validation exercise using the Habicht method, on the same child. In addition, mothers/caregivers and IMAM staff will also be asked to state their preference of Click-MUAC prototype and asked to give reasons for their preference.
The Click-MUAC devices are screening/diagnostic devices. Appropriate measures of agreement between the different measurer groups (mothers/primary caregivers, IMAM staff, gold standard) can be calculated from two-by-two contingency tables. The following appropriate measures of agreement will be calculated from these tables: sensitivity, specificity, accuracy, Cohen' s Kappa, Younden's J. The analysis (i.e. two-by-two contingency table and estimation of appropriate measures of agreement) will be performed for each prototype Click-MUAC device. A discordancy analysis will also be performed. The aim of the discordancy analysis is to describe misclassifications in terms of the range, interquartile range, and median MUAC at each type of discordancy. This analysis provides further calibration information that may inform design changes that avoid/minimize gross misclassifications and to minimize the frequency of errors made at or close to class boundaries.
- Conditions
- Malnutrition
- Being tested
- Click-MUAC prototype & regular MUAC tape
- Keywords
- Mid-Upper Arm Circumference (MUAC), Mother MUAC, Community screening for acute malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Click-MUAC prototype & regular MUAC tapeDevice
Screening of children using Click-MUAC and regular MUAC tape
| Study group | Role | What they receive |
|---|---|---|
| Click-MUAC & regular MUAC tape screening | Other | Each child will have nutritional status classified 11 times:
* 3 times with each of the 3 Click-MUAC prototypes by the mother/caregiver
* 1 time with a regular MUAC tape by the mother/caregiver
* 3 times with each of the 3 Click-MUAC prototypes by the case-finding/programme staff
* 1 time with a regular MUAC tape by the case-finding/programme staff
* 3 times with a regular MUAC tape by the data collection team ("gold standard") Receives: Device: Click-MUAC prototype & regular MUAC tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youden's J
Youden's J is a chance-corrected measure of agreement that can be interpreted as the probability of making an informed decision using a given method of ascertaining case-status. The measure is estimated as:
J = Sensitivity + Specificity - 1
Sensitivity is defined as the ability of the Click-MUAC device to correctly detect patients who do have the condition (i.e. either severe wasting or moderate wasting or any wasting). The measure is mathematically defined as: sensitivity = a/(a+b) where a= true positive and b= false negative
Specificity is defined as the ability of the Click-MUAC device to correctly detect patients who do not have the condition (i.e. either severe wasting or moderate wasting or any wasting). The measure is mathematically defined as specificity= d/(c+d) where d=true negative and c=false positive
Measured: Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to 3 months, for completion as planned for October 2016.
Secondary outcomes (2)
Accuracy
The term "accuracy" best applies to agreement between true case status (from the gold standard measurement procedure) and classification by mothers or program staff.
The measure is mathematically defined as accuracy= (a+d)/(a+b+c+d) where a= true positive, b= false negative, c=false positive and d=true negative
Measured: Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to 3 months, for completion as planned for October 2016.
Cohen's Kappa
Cohen's Kappa is defined mathematically as:
Cohen's Kappa= (p_o-p_e)/(1-p_e )
The term p_o is observed agreement (calculated from the two-by-two contingency table) and the term p_e is expected agreement (also calculated from the two-by-two contingency table). Cohen's Kappa can be used with square contingency tables larger than the two-by-two case. The measure is useful for evaluating a Click-Mid-Upper Arm Circumference (MUAC) device for more than two classes (e.g. severe wasting, moderate wasting, no wasting).
Measured: Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to three months, for completion as planned for October 2016.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Action Contre la Faim
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Brixton Health, Humanitarian Innovation Fund
- Responsible party
- Sponsor
- Investigators
- Angeline E Folliet-Grant, Principal investigator, Action Against Hunger | ACF-USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833740
- Sponsor's protocol ID
- USG5A
- Status last verified
- Jan 2017
- First submitted
- 12 May 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Grant A, Njiru J, Okoth E, Awino I, Briend A, Murage S, Abdirahman S, Myatt M. Comparing performance of mothers using simplified mid-upper arm circumference (MUAC) classification devices with an improved MUAC insertion tape in Isiolo County, Kenya. Arch Public Health. 2018 Feb 22;76:11. doi: 10.1186/s13690-018-0260-x. eCollection 2018.
PubMed 29484177
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Testing of a Set of Simplified Mid-upper Arm Circumference Classification Devices ("Click-MUAC") for Use by Mothers and Caregivers to Screen for Acute Malnutrition in Young Children at Community Level, in Isiolo County, Kenya
- ClinicalTrials.gov ID
- NCT02833740
- Acronym / sponsor ID
- USG5A
- Conditions
- Malnutrition
- Keywords
- Mid-Upper Arm Circumference (MUAC), Mother MUAC, Community screening for acute malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Action Contre la FaimUniversity, hospital or other
- Collaborators
- Tampere University, Brixton Health, Humanitarian Innovation Fund
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 14 Jul 2016 (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.
The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of a set of three simplified mid-upper arm circumference classification devices ("Click-MUAC") for use by mothers and caregivers to screen for acute malnutrition in young children. The study will be conducted in Isiolo County, Kenya. The study builds on the recent approach of training mothers to screen for acute malnutrition in their own children (mother MUAC approach).
The primary aim of the study is to describe and compare the performance of a set of three prototype Click-MUAC devices against a gold standard of classification, in terms of measures of agreement (sensitivity, specificity, accuracy, Cohen's Kappa, Youden's J) for the classification (diagnosis) of acute malnutrition. A secondary aim of the study is to determine the difference in agreement with the gold standard classification amongst mothers/caregivers using a Click-MUAC prototype versus mothers/caregivers using a regular MUAC tape. The hypothesis of the study is that at least one of the Click-MUAC prototypes is equal to the gold standard of classification in terms of measures of agreement for the classification of acute malnutrition. A secondary hypothesis of the study is that agreement with the gold standard classification is better amongst mothers/caregivers using a Click-MUAC prototype compared to mothers/caregivers using a regular MUAC tape. The outcomes of the study will be used to decide on whether production of a Click-MUAC device is desirable and, if this is the case, to select a design based on the performance of the prototype devices and the stated preferences of intended users.
Detailed description
The study will be a non-randomised, non-blinded, clinical diagnostic trial describing and comparing performance that will be conducted in two phases: (i) calibration of the devices, (ii) testing of Click-MUAC prototypes against "gold standard" classification.
The study will take place at designated health facilities within Isiolo County that already have an IMAM programme running. The investigators expect that the health facilities with the highest number of acute malnutrition admissions will be selected as study sites in order to be able to test the prototypes on a large number of attending Severe Acute Malnutrition (SAM)/Moderate Acute Malnutrition (MAM) children.
The first phase of work will concentrate on the calibration of Click-MUAC prototypes. The performance of the Click-MUAC prototypes with regard to accuracy of classification will be assessed in children with a measured MUAC at or close to the 115 mm and 125 mm case-defining thresholds. This phase of work is required as prior testing of the Click-MUAC prototypes will only have been performed on semi-rigid testing tubes.
The second phase of work will test the Click-MUAC prototypes. Three sets of measurements/classifications will be taken during the Click-MUAC testing trial: (i) Mother/caregiver MUAC classification performed by the mother/primary caregiver on their own child, using each of the three Click-MUAC prototypes and a regular MUAC tape; (ii) IMAM staff MUAC classification performed by the Integrated Management of Acute malnutrition (IMAM) staff on the same child, using each of the three Click-MUAC prototypes and a regular MUAC tape; (iii) Gold standard MUAC measurement performed by the study coordinator and/or data collection team members trained in the measurement of MUAC and selected for their accuracy (i.e. against the study supervisor) and precision of measurement, following a validation exercise using the Habicht method, on the same child. In addition, mothers/caregivers and IMAM staff will also be asked to state their preference of Click-MUAC prototype and asked to give reasons for their preference.
The Click-MUAC devices are screening/diagnostic devices. Appropriate measures of agreement between the different measurer groups (mothers/primary caregivers, IMAM staff, gold standard) can be calculated from two-by-two contingency tables. The following appropriate measures of agreement will be calculated from these tables: sensitivity, specificity, accuracy, Cohen' s Kappa, Younden's J. The analysis (i.e. two-by-two contingency table and estimation of appropriate measures of agreement) will be performed for each prototype Click-MUAC device. A discordancy analysis will also be performed. The aim of the discordancy analysis is to describe misclassifications in terms of the range, interquartile range, and median MUAC at each type of discordancy. This analysis provides further calibration information that may inform design changes that avoid/minimize gross misclassifications and to minimize the frequency of errors made at or close to class boundaries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Click-MUAC & regular MUAC tape screening | Other | Device: Click-MUAC prototype & regular MUAC tapeEach child will have nutritional status classified 11 times: * 3 times with each of the 3 Click-MUAC prototypes by the mother/caregiver * 1 time with a regular MUAC tape by the mother/caregiver * 3 times with each of the 3 Click-MUAC prototypes by the case-finding/programme staff * 1 time with a regular MUAC tape by the case-finding/programme staff * 3 times with a regular MUAC tape by the data collection team ("gold standard") |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child 6-59 months with MUAC < 115 mm presenting at health facility for treatment of acute malnutrition or identified at paediatric outpatient clinic.
- Child 6-59 months with MUAC < 115 mm currently enrolled in IMAM programme
- Child 6-59 months with MUAC between 115 mm and 125 mm presenting at health facility for treatment of acute malnutrition or identified at paediatric outpatient clinic.
- Child 6-59 months with MUAC between 115 mm and 125 mm currently enrolled in IMAM programme.
- Child 6-59 months with MUAC ≥ 125 mm identified at paediatric outpatient clinic.
Key exclusion criteria (6 listed)
- Child < 6 months or >59 months.
- Child with physical handicap preventing mid-upper arm circumference measurement.
- Child requiring immediate and urgent medical attention for medical complications.
- Child with mid-upper arm skin lesions (e.g. scabies, impetigo, ringworm).
- Bilateral pitting oedema.
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 |
|---|---|---|
| Click-MUAC prototype & regular MUAC tapeScreening of children using Click-MUAC and regular MUAC tape | Device | Click-MUAC & regular MUAC tape screening |
Primary outcome
Youden's J
Time frame: Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to 3 months, for completion as planned for October 2016.
Youden's J is a chance-corrected measure of agreement that can be interpreted as the probability of making an informed decision using a given method of ascertaining case-status. The measure is estimated as: J = Sensitivity + Specificity - 1 Sensitivity is defined as the ability of the Click-MUAC device to correctly detect patients who do have the condition (i.e. either severe wasting or moderate wasting or any wasting). The measure is mathematically defined as: sensitivity = a/(a+b) where a= true positive and b= false negative Specificity is defined as the ability of the Click-MUAC device to correctly detect patients who do not have the condition (i.e. either severe wasting or moderate wasting or any wasting). The measure is mathematically defined as specificity= d/(c+d) where d=true negative and c=false positive
2 secondary outcomes
Accuracy
Time frame: Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to 3 months, for completion as planned for October 2016.
Cohen's Kappa
Time frame: Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to three months, for completion as planned for October 2016.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 29484177Grant A, Njiru J, Okoth E, Awino I, Briend A, Murage S, Abdirahman S, Myatt M. Comparing performance of mothers using simplified mid-upper arm circumference (MUAC) classification devices with an improved MUAC insertion tape in Isiolo County, Kenya. Arch Public Health. 2018 Feb 22;76:11. doi: 10.1186/s13690-018-0260-x. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Angeline E Folliet-Grant principal investigator
Action Against Hunger | ACF-USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Click-MUAC prototype & regular MUAC tape in people with Malnutrition, run by Action Contre la Faim at 1 site in Kenya.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 2017. 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 Kenya. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angeline E Folliet-Grant (+41223216280, agrant@actionagainsthunger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youden's J (time frame: Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to 3 months, for completion as planned for October 2016.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833740, which also lists 1 linked publication.
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 31 Jan 2017.