Malnutrition's Role in Fall Risk

NCT03011918 | Unknown

• 1 other identifier: 13009-H06
• Study Type: observational
• Target: 485
• Locations: 1 country
• Sites: 1

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.

Conditions

Falling Injury; Nutrition Disorder

Outcome Measures

Primary Outcomes (1)

• Eat Well, Fall Less

  Multiphase descriptive analysis

  4 year

Study Arms (2)

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

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.

Other: Data Collection prior to first fall for all fallers; Other: Hgb value; Other: Vitamin D; Other: C-Reactive Protein

Interventions

Data Collection prior to first fall for all fallers OTHER

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

Also known as: percent weight loss

Observational Multiple event faller; Observational Single Event Faller

Hgb value OTHER

Hgb decline. Descriptive analysis of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected

Observational Multiple event faller; Observational Single Event Faller

Vitamin D OTHER

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..

Observational Multiple event faller; Observational Single Event Faller

C-Reactive Protein OTHER

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.

Observational Multiple event faller; Observational Single Event Faller

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized veterans having experiencced a fall between october 31, 2010 nad October 31, 2012

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead

Study Sites (1)

LSCVAMed Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Nutrition Disorders

Interventions

Vitamin D; C-Reactive Protein

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Immunoproteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Dietitian Nutritionist

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: January 6, 2017
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)