Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242684
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2005-10-18
Brief Title:
PEU in Elderly TCU Residents
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Manifestations Causes and Consequences of PEU in Elderly TCU Residents
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background There is tremendous controversy regarding the adequacyeffectiveness of the nutritional care provided in VA Transitional Care Units TCUs The interrelationship between concurrent inflammatory disease the adequacy of a residents nutrient consumption the development or resolution of putative nutritional deficits and clinical outcomes is not established Given the known obstacles to increasing nutrient intake eg 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 ie 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 statusillness 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
Objectives The primary objective of this study is to determine how best to define nutritional risk ie 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 statusillness 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
Detailed Description:
Background There is tremendous controversy regarding the adequacyeffectiveness of the nutritional care provided in VA Transitional Care Units TCUs The interrelationship between concurrent inflammatory disease the adequacy of a residents nutrient consumption the development or resolution of putative nutritional deficits and clinical outcomes is not established Given the known obstacles to increasing nutrient intake eg 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 ie 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 statusillness 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 hisher 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 eg 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 subjects study year each subject will be monitored by phone to determine survival and days of institutional eg hospital NH care At studys 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
Objectives The primary objective of this study is to determine how best to define nutritional risk ie 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 statusillness 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 hisher 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 eg 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 subjects study year each subject will be monitored by phone to determine survival and days of institutional eg hospital NH care At studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None