MalnutritionCNRSISNCT04751032
Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients
An observational study of Malnutrition and Old Age, run by Chinese Medical Association at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition, Old Age
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients in the geriatrics/geriatrics department of tertiary hospitals from September 2020 to September 2021 are consecutively enrolled.
Who may be able to join
- Patients aged ≥65 years old in geriatrics;
- Expected hospitalization ≥4 days;
- Patients with NRS 2002≥3 points;
- Sign informed notice.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Geriatrics,Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
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.
Read the 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.
- Conditions
- Malnutrition, Old Age
- Keywords
- malnutrition, older adults, adverse outcomes, nutrition intervention
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mortality
all cause mortality
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 90 days after hospitalization
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: Within 90 days after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Xiaohong Liu, MD &PHD, Principal investigator, Department of Geriatrics,Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751032
- Sponsor's protocol ID
- NCT2020090120210601
- Acronym
- CNRSIS
- Status last verified
- Oct 2020
- First submitted
- 23 Jan 2021
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40745263
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients
- ClinicalTrials.gov ID
- NCT04751032
- Acronym / sponsor ID
- CNRSIS / NCT2020090120210601
- Conditions
- Malnutrition, Old Age
- Keywords
- malnutrition, older adults, adverse outcomes, nutrition intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients in the geriatrics/geriatrics department of tertiary hospitals from September 2020 to September 2021 are consecutively enrolled.
Key inclusion criteria (4 listed)
- Patients aged ≥65 years old in geriatrics;
- Expected hospitalization ≥4 days;
- Patients with NRS 2002≥3 points;
- Sign informed notice.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of mortality
Time frame: within 90 days after hospitalization
all cause mortality
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.
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.
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.
3 secondary outcomes
Number of Participants with the albumin changes
Time frame: Within 90 days after hospitalization
Number of Participants with the physical function changes assessed by katz activity of the daily living（ADL）
Time frame: Within 90 days after hospitalization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 40745263Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohong Liu, MD &PHD principal investigator
Department of Geriatrics,Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Old Age, run by Chinese Medical Association at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mortality (time frame: within 90 days after hospitalization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.