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Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition

NCT02833740 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2017-01-31

No results posted yet for this study

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. 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.

Conditions

  • Malnutrition

Interventions

DEVICE

Click-MUAC prototype & regular MUAC tape

Screening of children using Click-MUAC and regular MUAC tape

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER

  • Brixton Health

    collaborator UNKNOWN

  • Humanitarian Innovation Fund

    collaborator UNKNOWN

  • Action Contre la Faim

    lead OTHER

Principal Investigators

  • Angeline E Folliet-Grant · Action Against Hunger | ACF-USA

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-02-28
Completion
2017-04-30

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833740 on ClinicalTrials.gov