Clinical trial NCT04751032: Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients
Official title: Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Old Age
Keywords: malnutrition
older adults
adverse outcomes
nutrition intervention
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2021-02-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of mortality
timeFrame: within 90 days after hospitalization
measure: Number of Participants with respiratory, urinary or gastrointestinal infections diagnosed by clinicians
timeFrame: within 90 days after hospitalization
measure: Number of Participants with unplanned hospitalization for acute illness
timeFrame: within 90 days after hospitalization
measure: Number of Participants with fall
timeFrame: within 90 days after hospitalization
Secondary outcomes:
measure: Number of Participants with the albumin changes
timeFrame: Within 90 days after hospitalization
measure: Number of Participants with the physical function changes assessed by katz activity of the daily living（ADL）
timeFrame: Within 90 days after hospitalization
measure: Number of Participants with the quality of the life changes according to the EuroQol Five Dimensions Questionnaire（EQ-5D）
timeFrame: Within 90 days after hospitalization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Geriatrics,Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Department of Geriatrics,Peking Union Medical College Hospital
name: Xiaohong Liu, MD &PHD
role: PRINCIPAL_INVESTIGATOR
References: