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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03632122
Other study ID # STUDY00005260
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date July 31, 2019

Study information

Verified date August 2019
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8344
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Short Physical Performance Battery (SPPB) 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
Primary Rehabilitation Use 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 Walking Capacity 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
Secondary Stair Climbing Capacity 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
Secondary Falls 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
Secondary Gait Speed Participants are timed as they finish a three meter walking course. 6 years
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