Falling InjuryNCT03011918
Malnutrition's Role in Fall Risk
An observational study of Falling Injury and Nutrition Disorder, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
Falls and falls related injuries are considered one of the most adverse events that a patient can experience. Several assessment instruments to assess and mitigate risks for falls have been developed. However, these instruments have not addressed nutritional risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Falling Injury, Nutrition Disorder
- What is being tested?
- Data Collection prior to first fall for all fallers, Hgb value and Vitamin D
- How many people
- 485 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized veterans having experiencced a fall between october 31, 2010 nad October 31, 2012
Who may be able to join
- Veteran experienced a fall during a hospitalization between October 1, 2010 and October 31, 2012
- Veteran must have at least one documented weight a minimum of 24 months prior to admission
Who cannot join
- Adults who suffer from neurological disease or stroke
- Adults with documented orthopedic fracture in the past 12 months
- Documented amputation of a lower limb in the past 24 months
- Blindness
- History of volume overload, renal, cardiovascular or other in nature
- current alcoholic
- It is felt that a co-morbidity exists which makes the individuals weight history inaccurate, such as a recent prosthetic device alteration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eat Well, Fall Less
Falls and falls related injuries are considered one of the most adverse events that a patient can experience. Several assessment instruments to assess and mitigate risks for falls have been developed. However, these instruments have not addressed nutritional risk factors.
Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the hospital setting is a significant concern and may play a role as a fall risk factor.
Read more
The World Health Organization (WHO) maintains a global anemia database. WHO has identified iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including industrialized nations.
The consensus statement of the Academy of Nutrition and Dietetics / American Society of Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of inadequate intake along with a multitude of other factors. Weight loss occurs at multiple points along this continuum.
this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss and degree of Hgb decline may be fall risk factors.
Read the detailed description
Eat Well, Fall Less is a multiphase retrospective descriptive analysis of single event fallers and repeat fallers. Data source: Documented falls occurring between October 1, 2010 and October 31, 2012.
Chart Review data on weight loss and decline in Hemoglobin levels were collected 12 months, 6 months and 3months and 1 month prior to the first fall along as the most recent value prior to the event. Additional data on vitamin D levels and C-reactive Protein values will be collected at the 12 month, 6month, and 1 month prior to the first fall
Statistical Analysis using SAS version 9.1. a two tailed t-test was performed to evaluate differences in HGB characteristics between single and frequent fallers. One way ANOVA evaluated changes in Hgb, c-Reactive Protein, vitamin D values and weight over time are being collected.
Two constellations of fallers emerged. Those with and those without dementia. The two groups appeared to have different nutrition risk factors. All statistical analysis was done using JMP Pro (version 10.0.0, SAS Institute, Inc, Cary, NC). Statistical significance was set at p < 0.05
- Conditions
- Falling Injury, Nutrition Disorder
- Being tested
- Data Collection prior to first fall for all fallers, Hgb value, Vitamin D, C-Reactive Protein
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data Collection prior to first fall for all fallersOther
Also called percent weight loss
Weight history. Descriptive analysis of weight history in single event fallers compared to multiple event fallers. Information on use of any nutrition supplementation exposure will also be collected
Hgb valueOther
Hgb decline. Descriptive analysis of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected
Vitamin DOther
Descriptive analysis of vitamin D status of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected..
C-Reactive ProteinOther
Descriptive analysis of C-RP value status of single event fallers as compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Observational Single Event Faller | one documented fall as an in-patient. It is hypothesized that the nutrition factors present prior to the first fall may be related to fall frequency. Data on exposure to nutrition supplementation will be collected for future analysis. Subpopulation alalysis of individuals with dementia will also be conducted Receives: Other: Data Collection prior to first fall for all fallers; Other: Hgb value; Other: Vitamin D; Other: C-Reactive Protein | |
| Observational Multiple event faller | multiple falls documented during in-patient stay It is hypothesized that frequent fallers will demonstrate statistically greater weight decline, Hgb decline, Vitamin D deficiency and Higher C-Reactive Protein values prior to the first fall. Data on exposure to nutrition supplementation will be collected for future analysis.. Subpopulation analysis of individuals with dementia will also be conducted. Receives: Other: Data Collection prior to first fall for all fallers; Other: Hgb value; Other: Vitamin D; Other: C-Reactive Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eat Well, Fall Less
Multiphase descriptive analysis
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startApr 2013
- Primary completionDec 2016
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falling InjuryStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mary M. Julius, RD,CDE, Louis Stokes VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011918
- Sponsor's protocol ID
- 13009-H06
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2015
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data collected in this study will be made available to future dietitians and Geriatric researchers obtaining an IRB approved protocol for ad hoc analysis.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat Well, Fall Less
- ClinicalTrials.gov ID
- NCT03011918
- Acronym / sponsor ID
- 13009-H06
- Conditions
- Falling Injury, Nutrition Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 485 participants (estimated)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- Apr 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Falls and falls related injuries are considered one of the most adverse events that a patient can experience. Several assessment instruments to assess and mitigate risks for falls have been developed. However, these instruments have not addressed nutritional risk factors.
Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the hospital setting is a significant concern and may play a role as a fall risk factor.
The World Health Organization (WHO) maintains a global anemia database. WHO has identified iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including industrialized nations.
The consensus statement of the Academy of Nutrition and Dietetics / American Society of Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of inadequate intake along with a multitude of other factors. Weight loss occurs at multiple points along this continuum.
this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss and degree of Hgb decline may be fall risk factors.
Detailed description
Eat Well, Fall Less is a multiphase retrospective descriptive analysis of single event fallers and repeat fallers. Data source: Documented falls occurring between October 1, 2010 and October 31, 2012.
Chart Review data on weight loss and decline in Hemoglobin levels were collected 12 months, 6 months and 3months and 1 month prior to the first fall along as the most recent value prior to the event. Additional data on vitamin D levels and C-reactive Protein values will be collected at the 12 month, 6month, and 1 month prior to the first fall
Statistical Analysis using SAS version 9.1. a two tailed t-test was performed to evaluate differences in HGB characteristics between single and frequent fallers. One way ANOVA evaluated changes in Hgb, c-Reactive Protein, vitamin D values and weight over time are being collected.
Two constellations of fallers emerged. Those with and those without dementia. The two groups appeared to have different nutrition risk factors. All statistical analysis was done using JMP Pro (version 10.0.0, SAS Institute, Inc, Cary, NC). Statistical significance was set at p < 0.05
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Single Event Faller | – | Other: Data Collection prior to first fall for all fallers, Other: Hgb value, Other: Vitamin D, Other: C-Reactive Proteinone documented fall as an in-patient. It is hypothesized that the nutrition factors present prior to the first fall may be related to fall frequency. Data on exposure to nutrition supplementation will be collected for future analysis. Subpopulation alalysis of individuals with dementia will also be conducted |
| Observational Multiple event faller | – | Other: Data Collection prior to first fall for all fallers, Other: Hgb value, Other: Vitamin D, Other: C-Reactive Proteinmultiple falls documented during in-patient stay It is hypothesized that frequent fallers will demonstrate statistically greater weight decline, Hgb decline, Vitamin D deficiency and Higher C-Reactive Protein values prior to the first fall. Data on exposure to nutrition supplementation will be collected for future analysis.. Subpopulation analysis of individuals with dementia will also be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized veterans having experiencced a fall between october 31, 2010 nad October 31, 2012
Key inclusion criteria (2 listed)
- Veteran experienced a fall during a hospitalization between October 1, 2010 and October 31, 2012
- Veteran must have at least one documented weight a minimum of 24 months prior to admission
Key exclusion criteria (7 listed)
- Adults who suffer from neurological disease or stroke
- Adults with documented orthopedic fracture in the past 12 months
- Documented amputation of a lower limb in the past 24 months
- Blindness
- History of volume overload, renal, cardiovascular or other in nature
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 |
|---|---|---|
| Data Collection prior to first fall for all fallersAlso: percent weight lossWeight history. Descriptive analysis of weight history in single event fallers compared to multiple event fallers. Information on use of any nutrition supplementation exposure will also be collected | Other | Observational Multiple event faller, Observational Single Event Faller |
| Hgb valueHgb decline. Descriptive analysis of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected | Other | Observational Multiple event faller, Observational Single Event Faller |
| Vitamin DDescriptive analysis of vitamin D status of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected.. | Other | Observational Multiple event faller, Observational Single Event Faller |
| C-Reactive ProteinDescriptive analysis of C-RP value status of single event fallers as compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure data will be collected. | Other | Observational Multiple event faller, Observational Single Event Faller |
Primary outcome
Eat Well, Fall Less
Time frame: 4 year
Multiphase descriptive analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: Yes. Data collected in this study will be made available to future dietitians and Geriatric researchers obtaining an IRB approved protocol for ad hoc analysis.
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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 Falling Injury and Nutrition Disorder, run by Louis Stokes VA Medical Center at 1 site in United States.
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 7 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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 United States. 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?
Results are not available in the source record.
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?
Eat Well, Fall Less (time frame: 4 year). 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 6 Jan 2017.