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

July 18, 2014 updated by: Amgen

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
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.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
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.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
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.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
Time Frame: Weeks 2, 14 and 26
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Anemia
Time Frame: Baseline
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
Time Frame: 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
Time Frame: Weeks 1, 14 and 26
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
Time Frame: Weeks 2, 14 and 26
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
Time Frame: Weeks 2, 14, 26
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
Time Frame: Weeks 2, 14, 26
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
Time Frame: Weeks 2, 14, 26
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.
Time Frame: Weeks 2, 14, 26
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
Time Frame: Weeks 2, 14, 26
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20050239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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