LEARN-6™: A Prospective, Observational Nursing Home Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00727571
First received: July 31, 2008
Last updated: July 18, 2014
Last verified: July 2014

July 31, 2008
July 18, 2014
September 2006
June 2008   (final data collection date for primary outcome measure)
Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).
The distance a subject walks, with or without an assistive device, and stand-by assistance of one person, or propels themselves in their wheelchair, with or without the use of their feet, over level ground [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00727571 on ClinicalTrials.gov Archive Site
  • Number of Participants With Anemia [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.
  • Percentage of Participants With Anemia Related Conditions at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative.

    Vitamin B12 and folate deficiency based on standard laboratory ranges.

  • Estimated Glomerular Filtration Rate (GFR) for Participants With CKD [ Time Frame: Weeks 1, 14 and 26 ] [ Designated as safety issue: No ]
    Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x [Serum creatinine]^-1.154 x [Age]^-0.203 x [0.742 if patient is female] x [1.210 if patient is black]. 2. Cockcroft-Gault formula: GFR = (140-age) * (Weight in kg) * (0.85 if female) / (72 * Serum Creatinine).
  • Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
    Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.
  • Physical Performance: Duration Walked or Wheeled at Each Visit [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.
  • Physical Performance: Time to Rise From Sitting to Standing [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.
  • Physical Performance: Grip Strength [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.
  • Physical Performance: Lower Extremity Strength, Left Leg. [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.
  • Physical Performance: Lower Extremity Strength, Right Leg [ Time Frame: Weeks 2, 14, 26 ] [ Designated as safety issue: No ]
    Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.
  • Proportion of subjects with anemia, defined by WHO criteria [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Among those with anemia, the proportion with anemia associated with CKD, nutritional deficiencies (iron, B12 and folate), GI bleed, and chronic disease based upon the study-specific anemia lab workup [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
  • For all subjects, calculated GFR using the MDRD 4-variable and Cockroft-Gault equations [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
  • Physical performance measures for all subjects with CKD, defined as eGFR <60 mL/min/1.73m2 [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
LEARN-6™: A Prospective, Observational Nursing Home Study
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

N/A (None Retained)

Probability Sample

Older, long-term stay Nursing Home (NH) residents with CKD, with and without anemia

  • Anemia
  • Chronic Kidney Disease
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
  • 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.
    Intervention: Other: Observations
  • 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.
    Intervention: Other: Observations
  • 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.
    Intervention: Other: Observations
  • 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.
    Intervention: Other: Observations
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
815
July 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00727571
20050239
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP