Nutritional RiskNCT04271982
Nutritional Risk and Use of Health Care Services
An observational study of Nutritional Risk and Malnutrition, run by Eva Biringer.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutritional Risk, Malnutrition
- How many people
- 270,560 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2018
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- Study A. Patients in hospital aged 65+
- Study B. All service users in municipalities aged 65+
Who cannot join
- Age <65 years
About this study
Official title: Nutritional Risk and Use of Health Care Services - a Missed Opportunity? A Cohort Study on Patients 65+
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.
- Conditions
- Nutritional Risk, Malnutrition
- Keywords
- Older, Population, Health services
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Hospital re-admission
Operationalised as number of admissions or time until admission (cohort A and B)
Measured: 2008-2020
Morbidity
Operationalised as number and severity of diagnoses (cohort A and B)
Measured: 2008-2020
Mortality
Operationalised as death or time until death (cohort A and B)
Measured: 2008-2020
Secondary outcomes (2)
Admission to nursing home
Admission to nursing home (cohort B)
Measured: 2017-2020
Extent of community health services received
Operationalised as type and number of hours/week (cohort B)
Measured: 2017-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2008
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270,560 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Eva Biringer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Western Norway University of Applied Sciences, Helse-Bergen HF
- Responsible party
- Sponsor-investigator, Eva Biringer, Helse Fonna
- Investigators
- Eva Biringer, PhD, Principal investigator, Helse Fonna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271982
- Sponsor's protocol ID
- 2018-01136
- Other IDs
- 2018
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Necessary legal and practical arrangements for data sharing have not yet been implemented in our region.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Risk and Use of Health Care Services - a Missed Opportunity? A Cohort Study on Patients 65+
- ClinicalTrials.gov ID
- NCT04271982
- Acronym / sponsor ID
- 2018-01136
- Conditions
- Nutritional Risk, Malnutrition
- Keywords
- Older, Population, Health services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270,560 participants (actual)
- Lead sponsor
- Eva BiringerUniversity, hospital or other
- Collaborators
- University of Bergen, Western Norway University of Applied Sciences, Helse-Bergen HF
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (2 listed)
- Study A. Patients in hospital aged 65+
- Study B. All service users in municipalities aged 65+
Key exclusion criteria (1 listed)
- Age <65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital re-admission
Time frame: 2008-2020
Operationalised as number of admissions or time until admission (cohort A and B)
Morbidity
Time frame: 2008-2020
Operationalised as number and severity of diagnoses (cohort A and B)
Mortality
Time frame: 2008-2020
Operationalised as death or time until death (cohort A and B)
2 secondary outcomes
Admission to nursing home
Time frame: 2017-2020
Extent of community health services received
Time frame: 2017-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No. Necessary legal and practical arrangements for data sharing have not yet been implemented in our region.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Biringer, PhD principal investigator
Helse Fonna
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Risk and Malnutrition, run by Eva Biringer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital re-admission (time frame: 2008-2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.