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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04271982
Other study ID # 2018-01136
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date December 31, 2018

Study information

Verified date February 2020
Source Helse Fonna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 270560
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Study A. Patients in hospital aged 65+

- Study B. All service users in municipalities aged 65+

Exclusion Criteria:

- Age <65 years

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Eva Biringer Helse-Bergen HF, University of Bergen, Western Norway University of Applied Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital re-admission Operationalised as number of admissions or time until admission (cohort A and B) 2008-2020
Primary Morbidity Operationalised as number and severity of diagnoses (cohort A and B) 2008-2020
Primary Mortality Operationalised as death or time until death (cohort A and B) 2008-2020
Secondary Admission to nursing home Admission to nursing home (cohort B) 2017-2020
Secondary Extent of community health services received Operationalised as type and number of hours/week (cohort B) 2017-2020
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