MalnutritionNCT03239093
Sixteen Years Trends in Reported Undernutrition in Switzerland
An observational study of Malnutrition and Epidemiology, run by Centre Hospitalier Universitaire Vaudois.
Trial summary
To assess 16-year trends in undernutrition reporting and management in Switzerland Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malnutrition, Epidemiology
- How many people
- 13,297,188 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 29 Jul 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalizations representing 98% of public and private hospitals within Switzerland
Who may be able to join
- adult patients (aged ≥20 years), length of hospital stay >1 day, not having any ICD-10 codes related to pregnancy, childbirth and puerperium (i.e. ICD-10 codes beginning with letter "O") as main diagnosis, and having complete demographic data and information on main diagnosis and mortality
Who cannot join
- -
About this study
To assess 16-year trends in undernutrition reporting and management in Switzerland
Read the detailed description
Analysis of data from the Swiss hospital discharge databases between 1998 and 2014. The database was provided by the Swiss federal office of statistics (http://www.bfs.admin.ch); it covers 98% of public and private hospitals within Switzerland and includes all stays for each hospital.
- Conditions
- Malnutrition, Epidemiology
- Being tested
- No intervention
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study using official data from the Federal Office of Statistics
What is being measured
The primary outcome is the main question the study is designed to answer.
undernutrition reporting
ICD-10 codes E12 (undernutrition-related diabetes mellitus), E40 (kwashiorkor), E41 (nutritional marasmus), E42 (marasmic kwashiorkor), E43 (unspecified severe protein-energy undernutrition), E44 (protein-energy undernutrition of moderate and mild degree), E46 (unspecified protein-energy undernutrition), R63 (R63.0: Anorexia, R63.3: feeding difficulties and mismanagement; R63.4: abnormal weight loss and R63.6: Insufficient intake of food and water due to self-neglect), and R64 (cachexia).
Measured: 1998-2014
Secondary outcomes (1)
nutritional management
CHOP codes related to enteral nutrition (96.6 and 96.35), parenteral nutrition (99.15), nutritional advice and therapy (89.0A.30, 89.0A.31 or 89.0A.32, depending on year) and multimodal nutritional therapy (89.0A.4*, where *=any number).
Measured: 1998-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jan 2017
- Primary completion29 Jul 2017
- Study completion29 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 13,297,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Marques-Vidal, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239093
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data request must be sent to the Swiss Federal Office of Statistics (http://www.bfs.admin.ch) and must comply with Swiss data protection rules
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sixteen Years Trends in Reported Undernutrition in Switzerland
- ClinicalTrials.gov ID
- NCT03239093
- Acronym / sponsor ID
- 1
- Conditions
- Malnutrition, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,297,188 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 29 Jul 2017 (actual)
- Study completion
- 29 Jul 2017 (actual)
- First posted
- 3 Aug 2017 (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.
To assess 16-year trends in undernutrition reporting and management in Switzerland
Detailed description
Analysis of data from the Swiss hospital discharge databases between 1998 and 2014. The database was provided by the Swiss federal office of statistics (http://www.bfs.admin.ch); it covers 98% of public and private hospitals within Switzerland and includes all stays for each hospital.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalizations representing 98% of public and private hospitals within Switzerland
Key inclusion criteria (1 listed)
- adult patients (aged ≥20 years), length of hospital stay >1 day, not having any ICD-10 codes related to pregnancy, childbirth and puerperium (i.e. ICD-10 codes beginning with letter "O") as main diagnosis, and having complete demographic data and information on main diagnosis and mortality
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study using official data from the Federal Office of Statistics | Other | – |
Primary outcome
undernutrition reporting
Time frame: 1998-2014
ICD-10 codes E12 (undernutrition-related diabetes mellitus), E40 (kwashiorkor), E41 (nutritional marasmus), E42 (marasmic kwashiorkor), E43 (unspecified severe protein-energy undernutrition), E44 (protein-energy undernutrition of moderate and mild degree), E46 (unspecified protein-energy undernutrition), R63 (R63.0: Anorexia, R63.3: feeding difficulties and mismanagement; R63.4: abnormal weight loss and R63.6: Insufficient intake of food and water due to self-neglect), and R64 (cachexia).
1 secondary outcome
nutritional management
Time frame: 1998-2014
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 3 Aug 2017.
- Individual participant dataSharing planned: No. Data request must be sent to the Swiss Federal Office of Statistics (http://www.bfs.admin.ch) and must comply with Swiss data protection rules
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Epidemiology, run by Centre Hospitalier Universitaire Vaudois.
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 1 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 3 Aug 2017. 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?
undernutrition reporting (time frame: 1998-2014). 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 3 Aug 2017.