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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727571
• Other study ID #: 20050239
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: July 18, 2014
• Start date: September 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Quorom Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Observations
This is a non-interventional, observational study; no investigational product is being used

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit	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).	Weeks 2, 14 and 26	No
Secondary	Number of Participants With Anemia	Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.	Baseline	No
Secondary	Percentage of Participants With Anemia Related Conditions at Baseline	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.	Baseline	No
Secondary	Estimated Glomerular Filtration Rate (GFR) for Participants With CKD	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).	Weeks 1, 14 and 26	No
Secondary	Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit	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.	Weeks 2, 14 and 26	No
Secondary	Physical Performance: Duration Walked or Wheeled at Each Visit	The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.	Weeks 2, 14, 26	No
Secondary	Physical Performance: Time to Rise From Sitting to Standing	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.	Weeks 2, 14, 26	No
Secondary	Physical Performance: Grip Strength	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.	Weeks 2, 14, 26	No
Secondary	Physical Performance: Lower Extremity Strength, Left Leg.	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.	Weeks 2, 14, 26	No
Secondary	Physical Performance: Lower Extremity Strength, Right Leg	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.	Weeks 2, 14, 26	No

External Links

•   AmgenTrials clinical trials website