Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions

August 14, 2019 updated by: Sean Rundell, University of Washington

Identifying Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions to Inform Pathways of Care and Improve Population Health

The overall goal of this study is to use the National Health and Aging Trends Study (NHATS) data to gain an understanding of how multiple chronic conditions impact the health outcomes of older adults with back pain.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

8344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

NHATS is a cohort of older adults and is representative of Medicare beneficiaries age 65 and older. It is a "unique national resource for the scientific study of functioning in later life." The sample is drawn from the Medicare enrollment files, and the survey oversamples Blacks and those at older ages. Initial NHATS data collection began in 2011 (Round 1) with in-person interviews.

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

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

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB)
Time Frame: 6 years
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).
6 years
Rehabilitation Use
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Capacity
Time Frame: 6 years
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.
6 years
Stair Climbing Capacity
Time Frame: 6 years
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.
6 years
Falls
Time Frame: 6 years
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".
6 years
Gait Speed
Time Frame: 6 years
Participants are timed as they finish a three meter walking course.
6 years

Collaborators and Investigators

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

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.

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 (Actual)

July 1, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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