LEARN-6™: A Prospective, Observational Nursing Home Study
NCT ID: NCT00727571
Last Updated: 2014-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
815 participants
OBSERVATIONAL
2006-09-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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No CKD or Anemia
Chronic kidney disease (CKD) is based on estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
Observations
This is a non-interventional, observational study; no investigational product is being used
No CKD, but Anemia
CKD is based on estimated GFR calculated by the MDRD method of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
Observations
This is a non-interventional, observational study; no investigational product is being used
CKD with Anemia
CKD is based on estimated GFR calculated by the MDRD method of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
Observations
This is a non-interventional, observational study; no investigational product is being used
CKD with no Anemia
CKD is based on estimated GFR calculated by the MDRD method of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
Observations
This is a non-interventional, observational study; no investigational product is being used
Interventions
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Observations
This is a non-interventional, observational study; no investigational product is being used
Eligibility Criteria
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Inclusion Criteria
* Long-term resident of NH as documented in medical record by Director of Nursing (DON) or Medical Director or as indicated in Minimum Data Set (MDS) Section Q
* Able to walk at least 1 step or propel wheelchair 1 revolution of wheel
* Able to follow a one-step instruction
* Written informed consent
Exclusion Criteria
* Receiving Renal Replacement Therapy (RRT)
* Major surgery within the past 3 months
* Life expectancy \< 6 months or receiving palliative care
* Currently enrolled in or has not yet completed at least 30 days since ending investigational device or drug study(s), or is receiving investigational agent(s)
* Currently is enrolled in an interventional trial
* Previously withdrawn from this study
65 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Binder EF, White HK, Resnick B, McClellan WM, Lei L, Ouslander JG. A prospective study of outcomes of nursing home residents with chronic kidney disease with and without anemia. J Am Geriatr Soc. 2012 May;60(5):877-83. doi: 10.1111/j.1532-5415.2012.03941.x. Epub 2012 May 9.
McClellan WM, Resnick B, Lei L, Bradbury BD, Sciarra A, Kewalramani R, Ouslander JG. Prevalence and severity of chronic kidney disease and anemia in the nursing home population. J Am Med Dir Assoc. 2010 Jan;11(1):33-41. doi: 10.1016/j.jamda.2009.07.003. Epub 2009 Nov 6.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20050239
Identifier Type: -
Identifier Source: org_study_id
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