Status:
COMPLETED
LEARN-6™: A Prospective, Observational Nursing Home Study
Lead Sponsor:
Amgen
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
65+ years
Brief Summary
This is a prospective, multicenter, observational, hypothesis-generating study exploring mobility, Quality of Life and other physical performance measures among older, long-term stay Nursing Home resi...
Detailed Description
Study Design: Multicenter, non-interventional, 26-week, prospective, observational study of older, long-term stay residents with CKD, with and without anemia, in US Nursing Homes.
Eligibility Criteria
Inclusion
- Age \> 65 years
- 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
- Admitted to NH for short stay rehabilitation (anticipated stay less than 3 months)
- 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- Previously withdrawn from this study
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
815 Patients enrolled
Trial Details
Trial ID
NCT00727571
Start Date
September 1 2006
End Date
July 1 2008
Last Update
July 25 2014
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