Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients (CNRSIS)

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Old Age

Detailed Description

This study is a multi-center observational study.Patients in the geriatrics department from September 2020 to September 2021 are consecutively enrolled .The patients' basic information, nutritional assessment, diet and blood biochemical indicators after hospitalization will be registered.The status of nutritional treatment and rehabilitation training and whether there is any adverse outcome when discharged from the hospital will be recorded. Daily energy, protein and fiber are 75% of the target amount as the standard for feeding.The diet, exercise status and adverse outcomes of participants within 90 days after hospitalization will be followed up through outpatient, telephone or remote consultation.Primary endpoint-the impact of nutritional therapy (energy, protein, dietary fiber compliance or failure) on mortality, new infections, falls and readmissions in elderly hospitalized patients within 90 days after hospitalization; secondary endpoints-the change of the nutrition indicators, the physical function and quality of life of the participants within 90 days after hospitalization.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Department of Geriatrics,Peking Union Medical College Hospital
      • Contact: Xiaohong Liu, MD &PHD; Phone Number: 18610003310; Email: xhliu41@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with the albumin changes	The albumin level of the 90-day follow-up and baseline will be measured in the unified laboratory using the same monitoring method, and the changes are used as the evaluation index of nutrition	Within 90 days after hospitalization
Number of Participants with the physical function changes assessed by katz activity of the daily living（ADL）	The Katz scale goes by the basics to evaluate a patient's level of independence or dependence.The 90-day follow-up and baseline ADL scores will be evaluated by trained elderly doctors, and the changes are used as the evaluation indicators for functional changes	Within 90 days after hospitalization
Number of Participants with the quality of the life changes according to the EuroQol Five Dimensions Questionnaire（EQ-5D）	the change of the score of the EQ-5D assessed by the participants.EQ-5D, EuroQol Five Dimensions Questionnaire, is a set of standardized scales for measuring health status. EQ-5D was developed by the European Society for Quality of Life (EuroQol), which can provide a simple and universal health measurement method. In the description part, five dimensions will be used to describe the health status. The five dimensions are: Mobility, Self-care, Usual Activities, Pain/Discomfort ), Anxiety/Depression. The questionnaire requires respondents to choose the most suitable option in each dimension according to their health status.	Within 90 days after hospitalization

Collaborators and Investigators

• Sponsor: Chinese Medical Association
• Investigators: Principal Investigator: Xiaohong Liu, MD &PHD, Department of Geriatrics,Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 14, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: older adults; malnutrition; nutrition intervention; adverse outcomes
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: NCT2020090120210601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No