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PEU in Elderly TCU Residents
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, November 2008
First Received: October 18, 2005   Last Updated: November 26, 2008   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00242684
  Purpose

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.


Condition
Aging

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • adverse clinical event [ Time Frame: post TCU admission ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

serum and plasma samples


Estimated Enrollment: 800
Study Start Date: March 2006
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
older patients admitted to a TCU unit

Detailed Description:

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.

Methods: To meet these objectives, 400 older, non-terminally ill veterans admitted to a VA TCU (where average length of stay is approx 90 days) will be prospectively studied using the same methodologic approach validated in prior VA hospital-based investigations. After completing a comprehensive admission assessment, each subject will be monitored closely throughout his/her TCU stay with serial nutrient intake and recurring metabolic, functional, neuropsychological, cognitive, nutritional, and medical assessments. Weights, anthropometrics, and blood for serum proteins, inflammatory markers (e.g., cytokines), and other select lab indices will be obtained at least monthly until discharged. Resting metabolic rate (by indirect calorimetry) will be obtained on select residents. Each subject will remain in the study for 12 months. From discharge through the end of the subject's study year, each subject will be monitored by phone to determine survival and days of institutional (e.g., hospital, NH) care. At study's end, strengths of associations will be assessed using univariable and multivariable analytic techniques including logistic and Cox Proportional-Hazards analyses.

Findings: No results at this time.

Status: Funding began 9-1-2005. Subject recruitment began 3-1-2006 and will continue for 4 more years. To date, we have recruited 293 subjects into the study. 282 subjects have been discharged from the inpatient phase of the study. The average length of stay for these subjects is 33 days.

Impact: Our study will provide a clearer understanding of what factors contribute to the apparent nutritional deficits seen in many older veterans residing in VA nursing home TCUs. The study will also lead to the development of a clinically useful system to identify TCU residents who are likely to benefit from specific interventions aimed at improving nutritional risk and thus clinical outcomes.

  Eligibility

Ages Eligible for Study:   64 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

non-terminally ill adults admitted to the TCU

Criteria

Inclusion Criteria:

> 64 years of age, admitted to the TCU

Exclusion Criteria:

If they: have a terminal disease (eg end-stage organ failure refractory to medical management receiving palliate care).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242684

Contacts
Contact: Melinda Bopp, BS (501) 257-2045 BoppMelindaM@uams.edu

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock Recruiting
No. Little Rock, Arkansas, United States, 72114-1706
Contact: Melinda Bopp, BS     501-257-2045     BoppMelindaM@uams.edu    
Principal Investigator: Dennis Sullivan, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Dennis Sullivan, MD Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Sullivan, Dennis - Principal Investigator )
Study ID Numbers: IIR 04-298
Study First Received: October 18, 2005
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00242684     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aging
Undernutrition
Inflammation
Frail Elderly

Study placed in the following topic categories:
Malnutrition
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009