- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632122
Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions
Identifying Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions to Inform Pathways of Care and Improve Population Health
Study Overview
Status
Conditions
Detailed Description
This study seeks to gain knowledge regarding how multiple chronic conditions affect the health and function of older adults with back pain. The investigators will perform a retrospective cohort study using secondary analysis of the National Health and Aging Trends Study (NHATS) data. NHATS collected longitudinal data on Medicare beneficiaries over 65 for six years, from 2011-2017. This set of data is comprehensive and includes self-reported survey data as well as physical performance data, both of which this study will utilize.
The specific aims include to 1) Estimate the longitudinal associations of the number of chronic conditions, using a standard classification scheme, with long-term physical performance, function, and recurrent falls, 2) Identify specific combinations of chronic conditions that are most strongly associated with long-term physical performance, function, and recurrent falls, 3) Determine the association of the number and type of chronic conditions with rehabilitation service use. The investigator will test a corresponding hypothesis for each aim: 1) Medicare beneficiaries reporting back pain with a greater number of chronic conditions will have worse physical performance, lower functional status, and be more likely to experience recurrent falls over 6 years, 2) Medicare beneficiaries reporting back pain with common and potentially modifiable conditions of anxiety, depression, and arthritis (individually and combined as dyads or a triad) will have worse physical performance, lower functional capacity, and be more likely to experience recurrent falls over 6 years, 3) Medicare beneficiaries with back pain and multiple chronic conditions will report lower use of rehabilitation services in the past one year compared to those with back pain alone or one additional chronic condition.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98105
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- This study will include community-dwelling participants in the NHATS study who indicated that in the last month they had been bothered by pain in the last month and indicated that the site of pain was the lower back.
Exclusion Criteria:
- This study will exclude participants who are non-ambulatory (requires wheelchair or scooter).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Bothersome back pain
The investigators will include community-dwelling older adults at Round 1 or 6 of the NHATS cohort, and will include those with bothersome back pain in the past month based on self-report questions at the respective baseline time point.
The investigators will exclude participants who are non-ambulatory (requires wheelchair or scooter).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Physical Performance Battery (SPPB)
Time Frame: 6 years
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NHATS measures physical performance using an in-person physical performance test.
The Short Physical Performance Battery, which includes walking 3 meters, balancing activities, and chair stands.
Participants are scored from 0 (worst) to 12 (best).
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6 years
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Rehabilitation Use
Time Frame: 1 year
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Participants asked if they had used rehabilitation services over the last year.
This is a dichotomous variable of "use" or "no use".
If participants answer that they have used rehabilitation services, they are asked the purpose/conditions for which they received care, the body region for which they received care, setting, duration of services in months and weeks, improvement of treatment and whether they met their treatment goals.
These are reported as categorical variables.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking Capacity
Time Frame: 6 years
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NHATS used survey questions asking about pairs of less or more challenging tasks.
This includes walking.
The pair of questions corresponding to walking capacity ask participants about their ability to walk 3 and 6 blocks by themselves.
Based on their answers participants were put into one of the following categories: unable to do less challenging task able to do less challenging task, able to do less challenging but not more challenging task, able to do the more challenging task.
Unable to do less challenging task the least functional capacity and able to do the most challenging task being the highest functional capacity.
Higher functional capacity is the better outcome.
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6 years
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Stair Climbing Capacity
Time Frame: 6 years
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NHATS used survey questions asking about pairs of less or more challenging tasks.
This includes stair climbing.
The pair of questions for stairs asks about the ability to go up 10 and 20 stairs.
Based on their answers participants were put into one of the following categories: unable to do less challenging task able to do less challenging task, able to do less challenging but not more challenging task, able to do the more challenging task.
Unable to do less challenging task the least functional capacity and able to do the most challenging task being the highest functional capacity.
Higher functional capacity is the better outcome.
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6 years
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Falls
Time Frame: 6 years
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The number of "falls" defined as "any fall, slip, or trip in which you lose your balance and land on the floor or ground at a lower level".
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6 years
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Gait Speed
Time Frame: 6 years
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Participants are timed as they finish a three meter walking course.
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6 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005260
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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