NCT04202939

Brief Summary

Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional status. Deterioration of the health status and of nutritional intake is further associated with chronic malnutrition, impaired quality of life, increased morbidity, mortality and long-term care. In order to ensure optimal nutritional care of nursing home residents and therefore have a lasting positive affect on their quality of life, morbidity and mortality, it is necessary:

  • to collect data on the quality of nutritional care in nursing homes by means of a simple method that requires no specialization in data acquisition,
  • to acquire knowledge on the prevalence of risk factors of malnutrition in nursing home residents in general and on individual nursing units, also in conjunction with the outcome after six months, and to forward the same to the individual nursing units,
  • to allow comparison with other facilities (with similar profile) with the help of a benchmarking system,
  • to assess the effectiveness of introduced changes in terms of quality management and quality improvement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2007

Completed
12.9 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

18.8 years

First QC Date

December 16, 2019

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dependence of nutritional intake on nutritional status and risk factors

    dependence of the outcome of nursing home residents' on their nutrient intake, their current nutritional status and risk factors (state of health, level of care

    180 days

Secondary Outcomes (1)

  • Nutrition-related structural parameters

    180 days

Study Arms (1)

nursing homes residents

all residents present in a nursing home unit on nutritionDay

Other: nutrition

Interventions

type and amount of food eaten or type of oral nutritional supplements as well as enteral or parenteral nutrition

Also known as: nursing home food, oral protein energy supplements, enteral nutrition, parenteral nutrition
nursing homes residents

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study evaluates nursing homes units and their residents who must be 50 years of age or older.

You may qualify if:

  • nursing home resident
  • minimum age: 50
  • present on nursing home unit on nutritionDay

You may not qualify if:

  • years and under
  • resident refused to participate in nutritionDay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (5)

  • Streicher M, Wirth R, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Dysphagia in Nursing Homes-Results From the NutritionDay Project. J Am Med Dir Assoc. 2018 Feb;19(2):141-147.e2. doi: 10.1016/j.jamda.2017.08.015. Epub 2017 Oct 10.

    PMID: 29030310BACKGROUND
  • Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. nutritionDay in Nursing Homes-The Association of Nutritional Intake and Nutritional Interventions With 6-Month Mortality in Malnourished Residents. J Am Med Dir Assoc. 2017 Feb 1;18(2):162-168. doi: 10.1016/j.jamda.2016.08.021. Epub 2016 Oct 11.

    PMID: 27742584BACKGROUND
  • Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Who receives oral nutritional supplements in nursing homes? Results from the nutritionDay project. Clin Nutr. 2017 Oct;36(5):1360-1371. doi: 10.1016/j.clnu.2016.09.005. Epub 2016 Sep 17.

    PMID: 27692932BACKGROUND
  • Wirth R, Streicher M, Smoliner C, Kolb C, Hiesmayr M, Thiem U, Sieber CC, Volkert D. The impact of weight loss and low BMI on mortality of nursing home residents - Results from the nutritionDay in nursing homes. Clin Nutr. 2016 Aug;35(4):900-6. doi: 10.1016/j.clnu.2015.06.003. Epub 2015 Jun 19.

    PMID: 26143743BACKGROUND
  • Valentini L, Schindler K, Schlaffer R, Bucher H, Mouhieddine M, Steininger K, Tripamer J, Handschuh M, Schuh C, Volkert D, Lochs H, Sieber CC, Hiesmayr M. The first nutritionDay in nursing homes: participation may improve malnutrition awareness. Clin Nutr. 2009 Apr;28(2):109-16. doi: 10.1016/j.clnu.2009.01.021. Epub 2009 Mar 5.

    PMID: 19264381BACKGROUND

Related Links

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional StatusEnteral NutritionParenteral Nutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsFeeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Michael J Hiesmayr, MD, MSc

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Hiesmayr, MD, MSc

CONTACT

Silvia Tarantino, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 18, 2019

Study Start

February 1, 2007

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Upon submission of a research proposal data anonymised data are shared with researcher. Each proposal is submitted to the supervisory board for approval.

Locations