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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00242684 |
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 |
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Aging |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents |
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 |
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1
older patients admitted to a TCU unit
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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.
Ages Eligible for Study: | 64 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
non-terminally ill adults admitted to the TCU
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).
Contact: Melinda Bopp, BS | (501) 257-2045 | BoppMelindaM@uams.edu |
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 |
Principal Investigator: | Dennis Sullivan, MD | Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock |
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 |
Aging Undernutrition Inflammation Frail Elderly |
Malnutrition Inflammation |