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PEU in Elderly TCU Residents

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ClinicalTrials.gov Identifier: NCT00242684
Recruitment Status : Completed
First Posted : October 20, 2005
Results First Posted : December 2, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease
Aging

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 approximately 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: See citations linked.

Status: Status: Funding began 9-1-2005. Subject recruitment began 3-1-2006. To date, we have recruited 446 subjects into the study. 446 subjects have been discharged from the inpatient phase of the study. The average length of stay for these subjects is 32 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.


Study Type : Observational
Actual Enrollment : 446 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents
Study Start Date : March 2006
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Group/Cohort
Group 1
older patients admitted to a TCU unit



Primary Outcome Measures :
  1. Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs [ Time Frame: While hospitalized on TCU, for up to 40 days ]

Biospecimen Retention:   Samples Without DNA
serum and plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   64 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242684


Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Dennis H. Sullivan, MD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00242684     History of Changes
Other Study ID Numbers: IIR 04-298
First Posted: October 20, 2005    Key Record Dates
Results First Posted: December 2, 2014
Last Update Posted: April 24, 2015
Last Verified: September 2014

Keywords provided by VA Office of Research and Development:
Aging
Undernutrition
Inflammation
Frail Elderly