Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632122
• Other study ID #: STUDY00005260
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Anxiety
• Back Pain
• Depression
• Low Back Pain
• Multiple Chronic Conditions
• Osteoarthritis

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