Clinical trial NCT03632122: Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions
Official title: Identifying Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions to Inform Pathways of Care and Improve Population Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Depression
Anxiety
Osteoarthritis
Keywords: comorbidity
pain
function
older adults
Medicare
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 8344
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: 6 years
measure: Rehabilitation Use
timeFrame: 1 year
Secondary outcomes:
measure: Walking Capacity
timeFrame: 6 years
measure: Stair Climbing Capacity
timeFrame: 6 years
measure: Falls
timeFrame: 6 years
measure: Gait Speed
timeFrame: 6 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
citation: Rundell SD, Karmarkar A, Nash M, Patel KV. Associations of Multiple Chronic Conditions With Physical Performance and Falls Among Older Adults With Back Pain: A Longitudinal, Population-based Study. Arch Phys Med Rehabil. 2021 Sep;102(9):1708-1716. doi: 10.1016/j.apmr.2021.03.025. Epub 2021 Apr 24.