MalnutritionNCT03759314
Identification of Risk Patients in Emergency Medical Services
An observational study of Malnutrition and Falling, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Background: Inadequate nutrition has been associated with growing risk of falling and impaired ability in elderly patients. Falling is a significant threat to the health of the elderly. It is estimated that one third of people over the age of 65 experience at least one falling each year. Read more about this study
- Who is it for?
- Ages 70 to 104 years
- Conditions the study is for
- Malnutrition, Falling, Cognitive Impairment
- What is being tested?
- Observation
- How many people
- 500 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2018to 28 Jan 2022
- 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 70 to 104 years
- All sexes
- No healthy volunteers
- Older adult
Study population: All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018 in the Helsinki University hospital area.
Who may be able to join
- All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland
Helsinki, Helsinki Usimaa
About this study
Background: Inadequate nutrition has been associated with growing risk of falling and impaired ability in elderly patients. Falling is a significant threat to the health of the elderly. It is estimated that one third of people over the age of 65 experience at least one falling each year. Over 60% of the falls cause serious injury or disability. Adequate nutrition increases the muscle strength of the elderly. Therefore, determining and managing the nutrition level is important for preventing falling. As far as we know emergency medical services has never before reported being a part of prevention by performing risk identification.
Read the detailed description
Aim: The purpose of the study is to assess whether it is possible to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the EMS faces the elderly over the age of 70 years. In addition, the flow of information between primary care and emergency services and nutritionists is examined.
Material and method: Identification of poor nutrition is carried out in the Helsinki University hospital area. All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018. A structured electronic form is used to identify the malnutrition, the level of cognitive functioning activity and the risk of falling. The assessment is performed during the transport. The data is analyzed by the SPSS statistical program both by descriptive and statistical significance by looking at the methods suitable for the data.
Conclusion: The information produced by the research aims to develop (a) Identifying in the ambulance those patients who are at risk; and (b) activating nursing staff and nutritionists and, by means of these measures, increase the number of patients receiving effective nutrition therapy.
- Conditions
- Malnutrition, Falling, Cognitive Impairment
- Being tested
- Observation
- Keywords
- EMS, elderly, nutrition, falling, cognitive functioning
- Medical subject headings
- Malnutrition, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying in the ambulance those patients who are at risk (over 3 points in a single section)
to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the EMS faces the elderly over the age of 70 The risk-screening tool is based on valid scales. RISK SCREENING TOOL;
Risk of falling:
Prediction of falls (4 items, 0-3 points) Self-reporting of falls over a 12-month period (3 items, 0-3 points)
Malnutrition Risk:
Home care and meal services (Yes, No) Nutritional status (4 items, 0-3 points) Effect of the diseases on nutrition (4 items, 0-3 points) Age (1 item, 1 point)
Delirium and cognitive functioning:
Alertness / memory / attention deficit / symptoms (4 items, 0-3 points)
Complete when:
> 70 years patient The patient's physical state allows. Mostly completed during transport (no need to add actual time on scene). Possible risk points are reported at donation to the emergency department.
Measured: Through study completion an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Sep 2018
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
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 Helsinki University Central HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Marja Mäkinen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759314
- Sponsor's protocol ID
- §50, 27.3.2018
- Status last verified
- Jan 2022
- First submitted
- 15 Nov 2018
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Patients in Emergency Medical Services
- ClinicalTrials.gov ID
- NCT03759314
- Acronym / sponsor ID
- §50, 27.3.2018
- Conditions
- Malnutrition, Falling, Cognitive Impairment
- Keywords
- EMS, elderly, nutrition, falling, cognitive functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 29 Nov 2018 (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.
Background: Inadequate nutrition has been associated with growing risk of falling and impaired ability in elderly patients. Falling is a significant threat to the health of the elderly. It is estimated that one third of people over the age of 65 experience at least one falling each year. Over 60% of the falls cause serious injury or disability. Adequate nutrition increases the muscle strength of the elderly. Therefore, determining and managing the nutrition level is important for preventing falling. As far as we know emergency medical services has never before reported being a part of prevention by performing risk identification.
Detailed description
Aim: The purpose of the study is to assess whether it is possible to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the EMS faces the elderly over the age of 70 years. In addition, the flow of information between primary care and emergency services and nutritionists is examined.
Material and method: Identification of poor nutrition is carried out in the Helsinki University hospital area. All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018. A structured electronic form is used to identify the malnutrition, the level of cognitive functioning activity and the risk of falling. The assessment is performed during the transport. The data is analyzed by the SPSS statistical program both by descriptive and statistical significance by looking at the methods suitable for the data.
Conclusion: The information produced by the research aims to develop (a) Identifying in the ambulance those patients who are at risk; and (b) activating nursing staff and nutritionists and, by means of these measures, increase the number of patients receiving effective nutrition therapy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 to 104 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018 in the Helsinki University hospital area.
Key inclusion criteria (1 listed)
- All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018.
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 |
|---|---|---|
| Observationto use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity | Other | – |
Primary outcome
Identifying in the ambulance those patients who are at risk (over 3 points in a single section)
Time frame: Through study completion an average of 12 months
to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the EMS faces the elderly over the age of 70 The risk-screening tool is based on valid scales. RISK SCREENING TOOL; Risk of falling: Prediction of falls (4 items, 0-3 points) Self-reporting of falls over a 12-month period (3 items, 0-3 points) Malnutrition Risk: Home care and meal services (Yes, No) Nutritional status (4 items, 0-3 points) Effect of the diseases on nutrition (4 items, 0-3 points) Age (1 item, 1 point) Delirium and cognitive functioning: Alertness / memory / attention deficit / symptoms (4 items, 0-3 points) Complete when: > 70 years patient The patient's physical state allows. Mostly completed during transport (no need to add actual time on scene). Possible risk points are reported at donation to the emergency department.
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 31 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Falling, run by Helsinki University Central Hospital at 1 site in Finland.
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 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Identifying in the ambulance those patients who are at risk (over 3 points in a single section) (time frame: Through study completion an average of 12 months). 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 31 Jan 2022.