- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271982
Nutritional Risk and Use of Health Care Services
Nutritional Risk and Use of Health Care Services - a Missed Opportunity? A Cohort Study on Patients 65+
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Study A. Patients in hospital aged 65+
- Study B. All service users in municipalities aged 65+
Exclusion Criteria:
- Age <65 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital re-admission
Time Frame: 2008-2020
|
Operationalised as number of admissions or time until admission (cohort A and B)
|
2008-2020
|
Morbidity
Time Frame: 2008-2020
|
Operationalised as number and severity of diagnoses (cohort A and B)
|
2008-2020
|
Mortality
Time Frame: 2008-2020
|
Operationalised as death or time until death (cohort A and B)
|
2008-2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Admission to nursing home
Time Frame: 2017-2020
|
Admission to nursing home (cohort B)
|
2017-2020
|
Extent of community health services received
Time Frame: 2017-2020
|
Operationalised as type and number of hours/week (cohort B)
|
2017-2020
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva Biringer, PhD, Helse Fonna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-01136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Malnutrition
-
HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; Stanford UniversityCompletedMalnutrition | Malnutrition in Children | Child MalnutritionBangladesh
-
University of Nove de JulhoUnknownMalnutrition, ChildBrazil
-
International Centre for Diarrhoeal Disease Research...UNICEFNot yet recruitingMalnutrition SevereBangladesh
-
UNICEFSave the ChildrenCompletedSevere MalnutritionCongo, The Democratic Republic of the
-
University of Erlangen-Nürnberg Medical SchoolPfrimmer Nutricia GmbH, Erlangen , GermanyCompletedNursing Home Residents | Malnutrition or Risk of MalnutritionGermany
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteNot yet recruitingModerate Acute Malnutrition | Severe Acute Malnutrition
-
Academy of Nutrition and DieteticsHartford Hospital; University of New Mexico; Meals on Wheels Central TexasNot yet recruiting
-
Diego MorettiSwiss Federal Institute of Technology; Wageningen University and Research; St... and other collaboratorsCompletedMalnutrition; ProteinSwitzerland
-
International Centre for Diarrhoeal Disease Research...CompletedProtein MalnutritionBangladesh