NCT04776070

Brief Summary

The prevalence of malnutrition is estimated at 30-50% of hospitalized patients in China. Disease-related malnutrition increases the risk of infection, mortality, length of hospitalization as well as the economic burden. National Nutrition Plan proposed to reduce malnutrition, but a clear, effective roadmap and protocol has not existed yet. Several factors impede to resolve the above challenges. They include :1) the low efficiency of current malnutrition diagnosis methods; 2) the lack of dynamic, standard method that can evaluate nutritional status in quantitative way. To this end, the investigators aim to establish an artificial-intelligence malnutrition diagnosis system to improve the application of malnutrition Clinical Pathway. Firstly, the investigators will establish a multidimensional malnutrition large data set, based on our previously built national hospital nutrition screening data set. It will contain deep 3D facial images, semi-structured and structured electronic medical record. Then, the investigators will use ensemble learning algorithm to establish a fully automatic, artificial-intelligence malnutrition diagnosis model that includes both etiological and phenotypic diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2022

Completed
Last Updated

March 29, 2023

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 25, 2021

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • malnutrition diagnosis

    Using Global Leadership Initiative on Malnutrition(GLIM) to diagnose malnutrition among hospitalized patients

    Within 48 hours of admission

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients in Peking Union Medical College

You may qualify if:

  • Adults (≥18 years old);
  • Within 48 hours of admission;
  • Inpatients at high risk of malnutrition, such as malignant tumors, chronic obstructive pulmonary disease, etc;
  • Han nationality;
  • Able to given informed consent.

You may not qualify if:

  • Patients with artificial facial changes (such as plastic surgery , head and neck radiotherapy , head and neck trauma);
  • Diseases with special facial changes (such as acromegaly);
  • High dose glucocorticoid users;
  • Patients with facial edema;
  • Emergency admission with an expected length of stay of less than 3 days;
  • Other conditions researchers thought could not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongcheng district,Peking union medical college hospital

Beijing, Beijing Municipality, 100010, China

Location

Related Publications (1)

  • Sun MY, Wang Y, Zheng T, Wang X, Lin F, Zheng LY, Wang MY, Zhang PH, Chen LY, Yao Y, Sun J, Li ZN, Hu HY, Jiang H, Yue HY, Zhao Q, Wang HY, Han L, Ma X, Ji MT, Xu HX, Luo SY, Liu YH, Zhang Y, Han T, Li YS, Hou PP, Chen W. Health economic evaluation of an artificial intelligence (AI)-based rapid nutritional diagnostic system for hospitalised patients: A multicentre, randomised controlled trial. Clin Nutr. 2024 Oct;43(10):2327-2335. doi: 10.1016/j.clnu.2024.08.030. Epub 2024 Aug 30.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

August 13, 2021

Primary Completion

April 21, 2022

Study Completion

May 21, 2022

Last Updated

March 29, 2023

Record last verified: 2021-02

Locations