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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anemia, Chronic Kidney Disease

Intervention / Treatment
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* Other: Observations


Participation Criteria
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Eligibility Criteria
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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or drug study(s), or is receiving investigational agent(s) Currently is enrolled in an interventional trial Previously withdrawn from this study

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No CKD or Anemia<br>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. | Other: Observations<br>* This is a non-interventional, observational study; no investigational product is being used<br>|
| No CKD, but Anemia<br>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. | Other: Observations<br>* This is a non-interventional, observational study; no investigational product is being used<br>|
| CKD with Anemia<br>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. | Other: Observations<br>* This is a non-interventional, observational study; no investigational product is being used<br>|
| CKD with no Anemia<br>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. | Other: Observations<br>* This is a non-interventional, observational study; no investigational product is being used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Chronic Kidney Disease, Quality of Life, CKD, Chronic Renal Insufficiency