NCT04751032

Brief Summary

This study is a multi-center observational study, led by the Department of Geriatrics, Peking Union Medical College Hospital, with 99 tertiary hospitals as sub-centers. Patients in the geriatrics department from September 2020 to September 2021 are consecutively enrolled .Basic information and nutritional risk assessment is registered and the outcome within 90 days after hospitalization will be recorded.Daily energy, protein and fiber are 75% of the target amount as the standard for feeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 4, 2025

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

January 23, 2021

Last Update Submit

May 1, 2025

Conditions

Keywords

malnutritionolder adultsadverse outcomesnutrition intervention

Outcome Measures

Primary Outcomes (4)

  • Rate of mortality

    all cause mortality

    within 90 days after hospitalization

  • Number of Participants with respiratory, urinary or gastrointestinal infections diagnosed by clinicians

    Any infection diagnosed by a formal medical institution.Infections that require a doctor's prescription of antibiotics indicated in the medical records or diagnosis reports provided by the participants, including the respiratory tract, urinary tract, gastrointestinal tract, etc.The report or diagnosis certificate has relevant evidence, for example, the test indicates that the white blood cell is increased or the high-sensitivity C-reactive protein is increased.

    within 90 days after hospitalization

  • Number of Participants with unplanned hospitalization for acute illness

    Visits reported by participants because of an acute illness rather than regular visits.Hospital stays longer than 48 hours will be counted, but outpatient visits will not be counted.

    within 90 days after hospitalization

  • Number of Participants with fall

    Any falls reported by the participants within 90 days will be recorded. The cause of the fall and whether it is accompanied by a fracture shall be recorded.

    within 90 days after hospitalization

Secondary Outcomes (3)

  • Number of Participants with the albumin changes

    Within 90 days after hospitalization

  • Number of Participants with the physical function changes assessed by katz activity of the daily living(ADL)

    Within 90 days after hospitalization

  • Number of Participants with the quality of the life changes according to the EuroQol Five Dimensions Questionnaire(EQ-5D)

    Within 90 days after hospitalization

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the geriatrics/geriatrics department of tertiary hospitals from September 2020 to September 2021 are consecutively enrolled.

You may qualify if:

  • Patients aged ≥65 years old in geriatrics;
  • Expected hospitalization ≥4 days;
  • Patients with NRS 2002≥3 points;
  • Sign informed notice.

You may not qualify if:

  • End-stage patients (estimated survival time ≤ 3 months);
  • Transfer to other departments during hospitalization;
  • Contraindications to nutritional therapy (such as hemodynamic instability);
  • Have participated in other nutritional research projects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatrics,Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • Li M, Jiang S, Li J, Chen X, Ma L, Guo Q, Wang Y, Luo L, An L, Wu Y, Huang W, Yuan L, Wang L, Ding X, Zhao X, Zhang Z, Zhang H, Wu Y, Yang R, Liu Y, Cao J, Liu X. Effectiveness and safety of oral nutrition in older patients with moderate dysphagia: a real-world cohort study in geriatric inpatients. BMC Geriatr. 2025 Jul 31;25(1):571. doi: 10.1186/s12877-025-06175-2.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Xiaohong Liu, MD &PHD

    Department of Geriatrics,Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2021

First Posted

February 11, 2021

Study Start

September 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 4, 2025

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations