Validation of the Mercy TAPE

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Abdel-Rahman, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier:
NCT01507090
First received: January 4, 2012
Last updated: February 6, 2015
Last verified: February 2015
Results First Received: July 22, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Weight
Intervention: Device: Mercy TAPE

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment from clinics, inpatient wards and referrals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Normal Children Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.

Participant Flow:   Overall Study
    Normal Children  
STARTED     642  
COMPLETED     624  
NOT COMPLETED     18  
incomplete dataset                 18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Normal Children Otherwise healthy children 2 months to 16 years of age.

Baseline Measures
    Normal Children  
Number of Participants  
[units: participants]
  642  
Age  
[units: participants]
 
<=18 years     642  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  8.4  (4.9)  
Gender  
[units: percentage¬†of¬†participants]
 
Female     51.7  
Male     48.3  
Region of Enrollment  
[units: participants]
 
United States     642  



  Outcome Measures
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1.  Primary:   Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)   [ Time Frame: study day 1 ]

2.  Primary:   Predictive Performance of the Mercy TAPE (Slope)   [ Time Frame: study day 1 ]

3.  Primary:   Predictive Performance of the Mercy TAPE (Intercept)   [ Time Frame: study day 1 ]

4.  Primary:   Predictive Performance of the Mercy TAPE (Mean Error)   [ Time Frame: study day 1 ]

5.  Primary:   Predictive Performance of the Mercy TAPE (Mean Percentage Error)   [ Time Frame: study day 1 ]

6.  Primary:   Predictive Performance of the Mercy TAPE (Corelation Coefficient)   [ Time Frame: study day 1 ]

7.  Primary:   Predictive Performance of the Mercy TAPE   [ Time Frame: study day 1 ]

8.  Primary:   Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)   [ Time Frame: study day 1 ]

9.  Primary:   Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)   [ Time Frame: study day 1 ]

10.  Primary:   Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)   [ Time Frame: study day 1 ]

11.  Secondary:   Inter-rater Reliability for the 2D and 3D Mercy TAPEs.   [ Time Frame: study day 1 ]

12.  Secondary:   Device Print Batch Variability   [ Time Frame: study day 1 ]

13.  Secondary:   Predictive Performance of the Mercy Method (Intercept)   [ Time Frame: study day 1 ]

14.  Secondary:   Predictive Performance of the Mercy Method (Slope)   [ Time Frame: study day 1 ]

15.  Secondary:   Predictive Performance of the Mercy Method (Percent of Participants)   [ Time Frame: study day 1 ]

16.  Secondary:   Predictive Performance of the Mercy Method (Mean Error)   [ Time Frame: study day 1 ]

17.  Secondary:   Predictive Performance of the Mercy Method (Mean Percentage Error)   [ Time Frame: study day 1 ]

18.  Secondary:   Predictive Performance of the Mercy Method   [ Time Frame: study day 1 ]

19.  Secondary:   Predictive Performance of the Mercy Method   [ Time Frame: study day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: Children's Mercy Hospital
phone: 816-234-3059
e-mail: srahman@cmh.edu


No publications provided by Children's Mercy Hospital Kansas City

Publications automatically indexed to this study:

Responsible Party: Susan Abdel-Rahman, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT01507090     History of Changes
Other Study ID Numbers: Mercy TAPE
Study First Received: January 4, 2012
Results First Received: July 22, 2014
Last Updated: February 6, 2015
Health Authority: United States: Food and Drug Administration