Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients

Malnutrition Clinical Trial

— CNRSIS  

Official title:

Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751032
• Other study ID #: NCT2020090120210601
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Chinese Medical Association
• Contact: Xiaohong Liu, MD &PHD
• Phone: 18610003310
• Email: xhliu41[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Old Age

Locations

Country	Name	City	State
China	Department of Geriatrics,Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of mortality	all cause mortality	within 90 days after hospitalization
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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