Study Complete
Sponsor ID
20050239
LEARN-6™: A Prospective, Observational Nursing Home Study
Study Details
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.
Protocol Summary
Primary Outcome Measures
The distance a subject walks up to ten minutes
Timeframe: Weeks 2, 14 and 26
Secondary Outcome Measures
Percentage of subjects with anemia, defined by World Health Organization (WHO) criteria
Timeframe: Week 2
Among those with anemia, the proportion with anemia associated with CKD, nutritional deficiencies (iron, B12 and folate), GI bleed, and chronic inflammation based upon the study-specific anemia lab workup
Timeframe: Baseline
For CKD subjects, estimated Glomerular Filtration Rate (GFR) using the Modification of Diet in Renal Disease (MDRD) 4-variable and Cockroft-Gault (CG) equations
Timeframe: Weeks 1, 14 and 26
Physical performance measures for distance traveled per unit time (speed of travel).
Timeframe: Weeks 2, 14 and 26
Physical performance measures for duration walked or wheeled.
Timeframe: Week 2, 14, 26
Physical performance measures for time to rise from sitting to standing.
Timeframe: Week 2, 14, 26
Physical performance measures for grip strength.
Timeframe: Week 2, 14, 26
Physical performance measures for lower extremity strength, left leg.
Timeframe: Week 2, 14, 26
Physical performance measures for lower extremity strength, right leg.
Timeframe: Week 2, 14, 26
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.