NCT05546034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 8, 2022

Last Update Submit

September 14, 2022

Conditions

Outcome Measures

Primary Outcomes (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.

    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.

    Within 6 months of completion of recruitment

Secondary Outcomes (1)

  • Validation of new score against GLIM

    Within 6 months of completion of recruitment

Interventions

None other than completion of questionnaires one of which would be done in routine practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-patient in department of internal medicine

You may qualify if:

  • In-patient in department of internal medicine

You may not qualify if:

  • Unable to complete questionnaire or in protective isolation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu Ülikooli Kliinikum

Tartu, Tartu, 50406, Estonia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Professor

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 19, 2022

Study Start

September 6, 2021

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations