NCT04271982

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
270,560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

11 years

First QC Date

February 13, 2020

Last Update Submit

February 13, 2020

Conditions

Keywords

OlderPopulationHealth services

Outcome Measures

Primary Outcomes (3)

  • Hospital re-admission

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

    2008-2020

  • Morbidity

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

    2008-2020

  • Mortality

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

    2008-2020

Secondary Outcomes (2)

  • Admission to nursing home

    2017-2020

  • Extent of community health services received

    2017-2020

Study Arms (2)

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)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Age \<65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Eva Biringer, PhD

    Helse Fonna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

January 1, 2008

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Necessary legal and practical arrangements for data sharing have not yet been implemented in our region.