PEU in Elderly TCU Residents
Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents
1 other identifier
observational
446
1 country
1
Brief Summary
Background: There is tremendous controversy regarding the adequacy/effectiveness of the nutritional care provided in VA Transitional Care Units (TCUs). The interrelationship between concurrent inflammatory disease, the adequacy of a resident's nutrient consumption, the development or resolution of putative nutritional deficits, and clinical outcomes is not established. Given the known obstacles to increasing nutrient intake (e.g. cost, resident acceptance, associated morbidity) and the lack of proven effectiveness of all forms of nutrition support and nutritional supplementation to improve clinical outcomes, a better understanding of these interrelationships is needed and will be the focus of this study. Objectives: The primary objective of this study is to determine how best to define nutritional risk (i.e., risk for adverse clinical outcomes due to inadequate nutrient intake) among older VA TCU residents. As part of this objective, we will seek to develop a better understanding of the interrelationship between nutrient intake, weight change, serum concentration of albumins, health status/illness severity, and mortality. The secondary objective is to develop a prediction model for identifying which TCU residents are likely to have ongoing problems with low nutrient intake. The ultimate objective is to develop a clinically useful system to identify residents who are likely to benefit from specific interventions aimed at improving nutritional risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
December 2, 2014
CompletedApril 24, 2015
September 1, 2014
6.1 years
October 18, 2005
November 24, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs
While hospitalized on TCU, for up to 40 days
Study Arms (1)
Group 1
older patients admitted to a TCU unit
Eligibility Criteria
non-terminally ill adults admitted to the TCU
You may qualify if:
- \> 64 years of age, admitted to the TCU
You may not qualify if:
- If they: have a terminal disease (eg end-stage organ failure refractory to medical management receiving palliate care).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706, United States
Related Publications (5)
Sullivan DH, Johnson LE, Dennis RA, Roberson PK, Garner KK, Padala PR, Padala KP, Bopp MM. Nutrient intake, peripheral edema, and weight change in elderly recuperative care patients. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):712-8. doi: 10.1093/gerona/gls234. Epub 2012 Nov 26.
PMID: 23183900RESULTDennis RA, Johnson LE, Roberson PK, Heif M, Bopp MM, Garner KK, Padala KP, Padala PR, Dubbert PM, Sullivan DH. Changes in activities of daily living, nutrient intake, and systemic inflammation in elderly adults receiving recuperative care. J Am Geriatr Soc. 2012 Dec;60(12):2246-53. doi: 10.1111/jgs.12007. Epub 2012 Nov 23.
PMID: 23176675RESULTSullivan DH, Roberson PK, Johnson LE, Mendiratta P, Bopp MM, Bishara O. Association between inflammation-associated cytokines, serum albumins, and mortality in the elderly. J Am Med Dir Assoc. 2007 Sep;8(7):458-63. doi: 10.1016/j.jamda.2007.04.004. Epub 2007 Aug 13.
PMID: 17845949RESULTSullivan DH, Johnson LE, Dennis RA, Roberson PK, Heif M, Garner KK, Bopp MM. The Interrelationships among albumin, nutrient intake, and inflammation in elderly recuperative care patients. J Nutr Health Aging. 2011 Apr;15(4):311-5. doi: 10.1007/s12603-010-0297-1.
PMID: 21437564RESULTDennis RA, Johnson LE, Roberson PK, Heif M, Bopp MM, Cook J, Sullivan DH. Changes in prealbumin, nutrient intake, and systemic inflammation in elderly recuperative care patients. J Am Geriatr Soc. 2008 Jul;56(7):1270-5. doi: 10.1111/j.1532-5415.2008.01789.x. Epub 2008 Jun 10.
PMID: 18547360RESULT
Biospecimen
serum and plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was an observational study designed to develop a better understanding of the interrelationships among nutrient intake, weight change, serum concentration of albumins, illness severity, and mortality. For more details, see cited references.
Results Point of Contact
- Title
- Melinda Bopp, Project Coordinator
- Organization
- Central Arkansas Veterans Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis H. Sullivan, MD
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
March 1, 2006
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 24, 2015
Results First Posted
December 2, 2014
Record last verified: 2014-09