Nutrition Screening - Route to a More Practical Method

Sponsor
University of Tartu (Other)
Overall Status
Completed
CT.gov ID
NCT05546034
Collaborator
(none)
300
1
6.5
46.1

Study Details

Study Description

Brief Summary

Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis.

No intervention undertaken.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Standard nutrition screening tools to be compared with routine blood tests

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

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Nutrition Screening - Route to a More Practical Method
Actual Study Start Date :
Sep 6, 2021
Actual Primary Completion Date :
Mar 23, 2022
Actual Study Completion Date :
Mar 23, 2022

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

Secondary Outcome Measures

  1. Validation of new score against GLIM [Within 6 months of completion of recruitment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

In-patient in department of internal medicine

Exclusion Criteria:

Unable to complete questionnaire or in protective isolation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tartu Ülikooli Kliinikum Tartu Tartumaa Estonia 50406

Sponsors and Collaborators

  • University of Tartu

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Alastair Forbes, Visiting Professor, University of Tartu
ClinicalTrials.gov Identifier:
NCT05546034
Other Study ID Numbers:
  • PKL-127
First Posted:
Sep 19, 2022
Last Update Posted:
Sep 19, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 19, 2022