Internal MedicineNCT05546034
Nutrition Screening - Route to a More Practical Method
An observational study of Internal Medicine, run by University of Tartu at 1 site in Estonia.
Trial summary
Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis. No intervention undertaken. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Medicine
- What is being tested?
- Standard nutrition screening tools to be compared with routine blood tests
- How many people
- 300 participants
- Where
- 1 siteEstonia
- Study dates
- 6 Sep 2021to 23 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In-patient in department of internal medicine
Who may be able to join
- In-patient in department of internal medicine
Who cannot join
- Unable to complete questionnaire or in protective isolation
Trial locations and contacts
1 site in 1 country.
About this study
Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis.
No intervention undertaken.
Read the detailed description
Nutrition screening is of established benefit but is difficult to ensure in ordinary clinical practice. It is relatively labour intensive. The investigation aims to determine whether routinely collected laboratory data could provide comparable information without the need for personnel time. It is known that individual blood tests do not provide sufficient sensitivity or specificity but it is hypothesised that combinations of tests could do so.
Included subjects are those admitted to the University Hospital department of internal medicine. All are eligible other than those subject to protective isolation for infection control (COVID, etc). Data collection is in the form of questionnaires to permit the calculation of 3 tools widely used for screening for malnutrition and malnutrition risk, namely the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening 2002 (NRS-2002) and the Subjective Global Assessment (SGA). Nutritional status is documented by the patient's status according to the international definition provided by the Global Leadership Initiative on Malnutrition (GLIM).
The blood tests already performed on a routine basis are captured to go alongside the nutrition screening tools.
Analysis will aim to determine whether combinations of laboratory data can simulate or replicate the information provided by MUST and NRS2002.
- Conditions
- Internal Medicine
- Being tested
- Standard nutrition screening tools to be compared with routine blood tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard nutrition screening tools to be compared with routine blood testsDiagnostic test
None other than completion of questionnaires one of which would be done in routine practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of new nutrition risk screening tool (devised from 200 patients) by validation in 100 contemporaneous patients in comparison with established screening tools (MUST, NRS-2002 and SGA) and malnutrition defined by GLIM.
Established tools for screening and assessing nutritional status are utilised. These are the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening-2002 (NRS-2002), the Subjective Global Assessment (SGA) and the Global Leadership Initiative on Malnutrition (GLIM). Data from laboratory testing that has already been performed on these patients is extracted from their hospital records. It is hypothesised that multivariate analysis of indicative parameters will identify 6 to 12 tests that can be combined (with appropriate weighting) into a new predictive score.
300 sets of patient data will be divided on a randomised basis into a group of 200 from whom the prospective new scoring system will be devised, and a group of 100 in whom the score will be tested for validity against NRS-2002.
Measured: Within 6 months of completion of recruitment
Secondary outcomes (1)
Validation of new score against GLIM
The intended new score will be tested against GLIM. The primary validation is against NRS-2002 as the score is intended as a screening tool for high risk of malnutrition, but it is important to determine whether it is also a test of established malnutrition.
Measured: Within 6 months of completion of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start6 Sep 2021
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
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 Internal MedicineStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alastair Forbes, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546034
- Sponsor's protocol ID
- PKL-127
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurik G, Kelly-Bissue C, Lohmus A, Muhhamedjanov K, Ilves N, Forbes A. Standardising and simplifying the Global Leadership Initiative on Malnutrition (GLIM) for its more general application. Clin Nutr ESPEN. 2024 Aug;62:120-127. doi: 10.1016/j.clnesp.2024.05.010. Epub 2024 May 18.
PubMed 38901933
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Screening - Route to a More Practical Method
- ClinicalTrials.gov ID
- NCT05546034
- Acronym / sponsor ID
- PKL-127
- Conditions
- Internal Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 19 Sep 2022 (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.
Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis.
No intervention undertaken.
Detailed description
Nutrition screening is of established benefit but is difficult to ensure in ordinary clinical practice. It is relatively labour intensive. The investigation aims to determine whether routinely collected laboratory data could provide comparable information without the need for personnel time. It is known that individual blood tests do not provide sufficient sensitivity or specificity but it is hypothesised that combinations of tests could do so.
Included subjects are those admitted to the University Hospital department of internal medicine. All are eligible other than those subject to protective isolation for infection control (COVID, etc). Data collection is in the form of questionnaires to permit the calculation of 3 tools widely used for screening for malnutrition and malnutrition risk, namely the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening 2002 (NRS-2002) and the Subjective Global Assessment (SGA). Nutritional status is documented by the patient's status according to the international definition provided by the Global Leadership Initiative on Malnutrition (GLIM).
The blood tests already performed on a routine basis are captured to go alongside the nutrition screening tools.
Analysis will aim to determine whether combinations of laboratory data can simulate or replicate the information provided by MUST and NRS2002.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-patient in department of internal medicine
Key inclusion criteria (1 listed)
- In-patient in department of internal medicine
Key exclusion criteria (1 listed)
- Unable to complete questionnaire or in protective isolation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard nutrition screening tools to be compared with routine blood testsNone other than completion of questionnaires one of which would be done in routine practice | Diagnostic test | – |
Primary outcome
Evaluation of new nutrition risk screening tool (devised from 200 patients) by validation in 100 contemporaneous patients in comparison with established screening tools (MUST, NRS-2002 and SGA) and malnutrition defined by GLIM.
Time frame: Within 6 months of completion of recruitment
Established tools for screening and assessing nutritional status are utilised. These are the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening-2002 (NRS-2002), the Subjective Global Assessment (SGA) and the Global Leadership Initiative on Malnutrition (GLIM). Data from laboratory testing that has already been performed on these patients is extracted from their hospital records. It is hypothesised that multivariate analysis of indicative parameters will identify 6 to 12 tests that can be combined (with appropriate weighting) into a new predictive score. 300 sets of patient data will be divided on a randomised basis into a group of 200 from whom the prospective new scoring system will be devised, and a group of 100 in whom the score will be tested for validity against NRS-2002.
1 secondary outcome
Validation of new score against GLIM
Time frame: Within 6 months of completion of recruitment
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 19 Sep 2022.
- Derived from this study: PubMed 38901933Kurik G, Kelly-Bissue C, Lohmus A, Muhhamedjanov K, Ilves N, Forbes A. Standardising and simplifying the Global Leadership Initiative on Malnutrition (GLIM) for its more general application. Clin Nutr ESPEN. 2024 Aug;62:120-127. doi: 10.1016/j.clnesp.2024.05.010. Epub 2024 May 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Internal Medicine, run by University of Tartu at 1 site in Estonia.
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 1 inclusion and 1 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 19 Sep 2022. 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 Estonia. 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?
Evaluation of new nutrition risk screening tool (devised from 200 patients) by validation in 100 contemporaneous patients in comparison with established screening tools (MUST, NRS-2002 and SGA) and malnutrition defined by GLIM. (time frame: Within 6 months of completion of recruitment). 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 NCT05546034, 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 19 Sep 2022.