Nutritional Risk and Nutritional Care Practices in the Hospitalized Elderly (NUTRIELD)

January 12, 2015 updated by: Kari Almendingen, Oslo Metropolitan University

Nutritional Status and Care of Elderly People

The purpose of this study is to estimate the prevalence of nutritional risk and examine nutritional care practices in the hospitalized elderly at one large university hospital in Norway.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

A cross-sectional study was designed and carried out at a university hospital in Norway. The study was developed by a collegium at a nursing bachelor education program in a multidisciplinary collaboration with representatives from the university hospital and other experts. Data on nutritional risk and nutritional care practices of elderly patients were collected by 173 second year nursing students at the university college in question who were undergoing their acute and clinical care practice studies on 20 wards at the university hospital. Nine nutritional screening days were conducted in the academic years 2011/2012 and 2012/2013. On the screening days the students filled in the questionnaire for each patient, including questions about age, gender, length of hospital stay, normal weight in recent months, weight, height, BMI, nutritional risk and nutritional care practices. The students measured weight and height whenever possible, and screened the patients for nutritional risk. Data were collected by using a stratified sampling technique along with adequate power calculations to improve the representativeness of the sample. The researchers received anonymously completed questionnaires and screening forms from the students and never met the patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were recruited from a large University hospital in Norway. The university hospital covers about 10% of the Norwegian population, providing healthcare services for approximately half a million people living in urban and rural municipalities. The patient population is thus heterogenic with respect to ethnicity and socioeconomic factors. All somatic wards having nursing students in acute care clinical studies in autumn 2011 were included in the study. The study sample comprised 14 of 16 medical and surgical somatic wards. Additionally, one rehabilitation ward, one specialized short time unit, one emergency medicine ward, and one cardio-monitoring ward were included.

Eligible patients were selected by the nursing students in cooperation with the ward nursing staff.

Description

Inclusion Criteria:

  • All elderly (≥70 yrs) patients admitted on the included wards at 08.00 am on the screening days were asked to participate.

Exclusion Criteria:

  • Terminal patients (assumed short-lived, <1 month), patients diagnosed with dementia and patients whom the ward staff found unfit to participate were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nutritional risk
Time Frame: 9 screening days were conducted in 2011-2013
Patients was screened for nutritional risk on 9 screening days conducted in the academic years of 2011/2012 and 2012/2103. The Nutritional Risk Screening Tool 2002 (NRS2002) was employed to identify nutritional risk in the patients.
9 screening days were conducted in 2011-2013

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional care practices
Time Frame: 9 nutritional screening days were conducted in the period 2011-2013
Questions regarding the nutritional care practices concerned weight measurements on admission and then weekly, conduction of nutritional risk screening, coding of undernutrition diagnosis (E43, E44, or E46) in line with the International Statistical Classification of Diseases and Related Health Problems (ICD-10), and initiation of nutritional measures.
9 nutritional screening days were conducted in the period 2011-2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo Metropolitan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Akershus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kari Almendingen, Professor, Oslo Metropolitan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-2719007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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