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CompletedNCT04271982Updated Feb 17, 2020

Nutritional Risk and Use of Health Care Services

An observational study in Nutritional Risk and Malnutrition, sponsored by Eva Biringer. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Eva Biringer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
270,560
Ages
65 Years and older
Sex
All
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Study summary

This longitudinal observation study investigates associations between nutritional risk in adults aged 65+ and use of health services, morbidity and mortality. The first hypothesis is that older service users at nutritional risk will use a higher number of services/consultations and have a higher morbidity and mortality, compared to older patients not at nutritional risk. Further, the study evaluates the usefulness of the tool 'nutrition plan'. The second hypothesis is that older service users at nutritional risk who have a nutrition plan have lower subsequent morbidity and mortality, compared to older service users at nutritional risk without a nutrition plan.

Read the detailed description

The study is divided into two main parts, based on two different populations.

Study A: Article 1 is based on 'The Undernutrition Registry' in Helse Bergen Local Health Authority, Norway. The Undernutrition registry is a cohort of patients (n=20 000) screened for nutritional risk at Haukeland University Hospital (HUS) during point prevalence surveys between 2008 and 2018. The point prevalence surveys included all adult patients in somatic departments, and were performed 2-4 times per year. Detailed descriptions of the data collection can be found in Tangvik et al. (2012). Previous analysis showed that 43% of the patients in the sample were above 70 years, thus we expect the sample in the study to constitute approx. 9000 patients ≥ 65 years. Nutritional risk was determined by 'Nutritional Risk Screening 2002' (NRS2002). Information on nutritional risk will be linked to data on health care use and outcomes from the hospital's patient administrative electronic database (length of stay, number of hospital stays, morbidity in terms of number and severity of diagnoses and death).

Study B: Articles 2 and 3 are based on a cohort of older service users (≥65 years) with information on nutritional variables from the 'Kommunalt pasientregister' (KPR)-registry in the period 2016-2018 (N=270,560). Municipalities report data on nutritional risk screening and nutritional plan for individual service users in KPR. These nutritional data will be linked to data from 'The Norwegian Patient Registry' (NPR). NPR includes information about diagnosis and use of specialist services for all patients who have received or are waiting for treatment/consultations in specialist health care services (hospitals and outpatient clinics).

Nutritional status and use of 'nutritional plan' will be entered as independent variables in regression and survival analysis models with health service use (type, extent) or mortality as outcome variables.

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Conditions studied

  • Nutritional Risk
  • Malnutrition

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Keywords

  • Older
  • Population
  • Health services
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 270,560 is above the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

This is the only study on the registry with Eva Biringer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Two cohorts of adults aged 65+: Cohort A includes in-patients in Haukeland University Hospital (HUS), cohort B includes services users in all Norwegian municipalities

Inclusion criteria

  • Study A. Patients in hospital aged 65+
  • Study B. All service users in municipalities aged 65+

Exclusion criteria

Exclusion Criteria:

  • Age \<65 years
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
270,560 participants (actual)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Cohort A

    Cohort A includes patients (N=20 000) screened for nutritional risk at Haukeland University Hospital (HUS) during point prevalence surveys between 2008 and 2018. The point prevalence surveys included all adult patients in somatic departments, and were performed 2-4 times per year since 2008. We expect the sample in the study to include approx. 9000 patients ≥ 65 years.

  • Cohort B

    Cohort B includes older service users (≥65 years) with information on nutrition variables from the KPR-registry in the period 2016 to 2018 (n=approx. 270 560). All Norwegian municipalities report data on nutritional risk screening and nutrition plan for individual service users in "Kommunalt pasientregister" (KPR). These nutritional data will be linked to registry data on health care services use and patient outcome variables from the "The Norwegian Patient Registry" (NPR)

06

What researchers measure

Primary outcomes

  1. Hospital re-admission

    Operationalised as number of admissions or time until admission (cohort A and B)

    Time frame: 2008-2020

  2. Morbidity

    Operationalised as number and severity of diagnoses (cohort A and B)

    Time frame: 2008-2020

  3. Mortality

    Operationalised as death or time until death (cohort A and B)

    Time frame: 2008-2020

Secondary outcomes

  1. Admission to nursing home

    Admission to nursing home (cohort B)

    Time frame: 2017-2020

  2. Extent of community health services received

    Operationalised as type and number of hours/week (cohort B)

    Time frame: 2017-2020

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Necessary legal and practical arrangements for data sharing have not yet been implemented in our region.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04271982
Lead sponsor
Eva Biringer
Collaborators
University of Bergen, Western Norway University of Applied Sciences, Helse-Bergen HF
Responsible party
Eva Biringer (Senior Researcher, Helse Fonna) — Sponsor-investigator
First posted
Feb 17, 2020
Start date
Jan 1, 2008
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Feb 17, 2020

Study contacts

Eva Biringer, PhD
principal investigator · Helse Fonna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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