Malnutrition's Role in Fall Risk

Falling Injury Clinical Trial

Official title:

Eat Well, Fall Less

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03011918
• Other study ID #: 13009-H06
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 31, 2015
• Last updated: January 5, 2017
• Start date: April 2013
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Louis Stokes VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 485
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Falling Injury
• Nutrition Disorder
• Nutrition Disorders

Intervention

Other:
• Data Collection prior to first fall for all fallers
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 value
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 D
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 Protein
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.

Locations

Country	Name	City	State
United States	LSCVAMed Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eat Well, Fall Less	Multiphase descriptive analysis	4 year	No