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NCT Number: NCT04751032

Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Old Age

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Geriatrics,Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Rate of mortality

    Time frame: within 90 days after hospitalization

    all cause mortality

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

    Time frame: within 90 days after hospitalization

    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.

  3. Number of Participants with unplanned hospitalization for acute illness

    Time frame: within 90 days after hospitalization

    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.

  4. Number of Participants with fall

    Time frame: within 90 days after hospitalization

    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.

Secondary outcomes

  1. Number of Participants with the albumin changes

    Time frame: Within 90 days after hospitalization

    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

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

    Time frame: Within 90 days after hospitalization

    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

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

    Time frame: Within 90 days after hospitalization

    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.

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Acronym: CNRSIS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2021
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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