Clinical trial NCT00727571: LEARN-6™: A Prospective, Observational Nursing Home Study
Official title: Prospective Observational Study to Evaluate Physical Performance and Quality of Life in Older Long Stay Nursing Home Residents With Chronic Kidney Disease With and Without Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Chronic Kidney Disease
Keywords: Anemia
Chronic Kidney Disease
Quality of Life
CKD
Chronic Renal Insufficiency
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-08-04
Enrollment: 815
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older, long-term stay Nursing Home (NH) residents with CKD, with and without anemia

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 residents with CKD, with versus without anemia. Enrolled patients will participate in the study up to a total of 26 weeks and be assessed at Weeks 1, 2, 14 and 26/End of Study. Based upon Week 1 hemoglobin and serum creatinine lab results, participants will be categorized into 1 of 4 groups.

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 Criteria:

* 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 Criteria:

* 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* Previously withdrawn from this study

Primary outcomes:
measure: Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
timeFrame: Weeks 2, 14 and 26
Secondary outcomes:
measure: Number of Participants With Anemia
timeFrame: Baseline
measure: Percentage of Participants With Anemia Related Conditions at Baseline
timeFrame: Baseline
measure: Estimated Glomerular Filtration Rate (GFR) for Participants With CKD
timeFrame: Weeks 1, 14 and 26
measure: Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
timeFrame: Weeks 2, 14 and 26
measure: Physical Performance: Duration Walked or Wheeled at Each Visit
timeFrame: Weeks 2, 14, 26
measure: Physical Performance: Time to Rise From Sitting to Standing
timeFrame: Weeks 2, 14, 26
measure: Physical Performance: Grip Strength
timeFrame: Weeks 2, 14, 26
measure: Physical Performance: Lower Extremity Strength, Left Leg.
timeFrame: Weeks 2, 14, 26
measure: Physical Performance: Lower Extremity Strength, Right Leg
timeFrame: Weeks 2, 14, 26
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.