Clinical trial NCT03011918: Malnutrition's Role in Fall Risk
Official title: Eat Well, Fall Less
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Falling Injury
Nutrition Disorder
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
First posted: 2017-01-06
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized veterans having experiencced a fall between october 31, 2010 nad October 31, 2012

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Eat Well, Fall Less
timeFrame: 4 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: LSCVAMed Center
state: Ohio
Study officials:
References: