AgingNCT00242684
PEU in Elderly TCU Residents
An observational study of Aging, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 64 years and older
- Conditions the study is for
- Aging
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Apr 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 64 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-terminally ill adults admitted to the TCU
Who may be able to join
- > 64 years of age, admitted to the TCU
Who cannot join
- If they: have a terminal disease (eg end-stage organ failure refractory to medical management receiving palliate care).
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706
About this study
Official title: Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents
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.
Read the 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.
- Conditions
- Aging
- Keywords
- Aging, Undernutrition, Inflammation, Frail Elderly
- Medical subject headings
- Malnutrition, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | older patients admitted to a TCU unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs
Measured: While hospitalized on TCU, for up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startMar 2006
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dennis H. Sullivan, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242684
- Sponsor's protocol ID
- IIR 04-298
- Status last verified
- Sep 2014
- First submitted
- 18 Oct 2005
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23183900Dennis 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.
PubMed 23176675Sullivan 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.
PubMed 17845949Sullivan 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.
PubMed 21437564Dennis 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.
PubMed 18547360
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents
- ClinicalTrials.gov ID
- NCT00242684
- Acronym / sponsor ID
- IIR 04-298
- Conditions
- Aging
- Keywords
- Aging, Undernutrition, Inflammation, Frail Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Oct 2005 (estimated)
- Results
- Posted 2 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –older patients admitted to a TCU unit |
Who may qualify
- Ages
- 64 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-terminally ill adults admitted to the TCU
Key inclusion criteria (1 listed)
- > 64 years of age, admitted to the TCU
Key exclusion criteria (1 listed)
- If they: have a terminal disease (eg end-stage organ failure refractory to medical management receiving palliate care).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs
Time frame: While hospitalized on TCU, for up to 40 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23183900Sullivan 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.
- Results publication: PubMed 23176675Dennis 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.
- Results publication: PubMed 17845949Sullivan 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.
- Results publication: PubMed 21437564Sullivan 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.
- Results publication: PubMed 18547360Dennis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis H. Sullivan, MD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs (time frame: While hospitalized on TCU, for up to 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242684, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.