Classifying and Predicting Long-term Pain and Function in Older Adults

April 27, 2021 updated by: Sean Rundell, University of Washington

A New Approach to Classifying and Predicting Long-term Bothersome Pain and Functional Decline in Older Adults

This project will use novel methods to detect clinically meaningful subgroups of older adults based on long-term trajectories of bothersome pain and function. It will then identify older adults at high risk of experiencing poor long-term pain and function. Anticipated results will provide new insights into long-term patterns of pain and function across the aging process and identify potential predictors of each trajectory.

Study Overview

Status

Completed

Conditions

Detailed Description

The long-term goal of this planned line of research is to reduce the burden of pain and maximize function in older adults as they age. This line of research will begin by completing the following Aims: Aim 1) Identify and describe clinically meaningful long-term trajectories of bothersome pain and functional decline in a population-based sample of older adults and Aim 2) Estimate the association between candidate prognostic factors typically available in electronic health records and long-term bothersome pain and function trajectories to inform the development of eventual risk prediction models. This will be a retrospective cohort study using longitudinal data from the population-based National Health and Aging Trends Study (NHATS). This project will use novel methods to identify clinically meaningful subgroups of older adults based on long-term trajectories of bothersome pain and function. Group-based trajectory modeling (GBTM) is a novel method to model dynamic phenomena such as pain and function. Older adults at high risk of experiencing poor long-term pain and function outcomes will be identified by leveraging potential prognostic factors typically available in electronic health records or administrative data. It is anticipated that our results will provide new insights into long-term patterns of pain and function across the aging process and identify potential predictors of each trajectory.

Study Type

Observational

Enrollment (Actual)

6783

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 years 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. NHATS data collection began in 2011 (Round 1) with in-person interviews. Participants were re-interviewed yearly (Rounds 2-7). This is a unique cohort because it contains comprehensive survey data in addition to physical performance measures for individuals over multiple years. During each round, NHATS collects a wide array of information during the interviews, including: demographic, health, social, economic, environmental, cognitive, behavioral, and physical data.

Description

Inclusion Criteria:

  • community-dwelling older adults from Round 1 of the NHATS cohort

Exclusion Criteria:

  • participants who are non-ambulatory (require a wheelchair or scooter for mobility) at Round 1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bothersome Pain
Time Frame: 6 years
Question: "In the last month, have you been bothered by pain?" Dichotomous response of yes or no
6 years
Physical Performance
Time Frame: 6 years
Short Physical Performance Battery (SPPB). Scored from 0=worst to 12=best based on 3 performance tests: walking, chairs stands, and balance tasks
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity Limitations Due to Pain
Time Frame: 6 years
Question: "In the last month, has pain ever limited your activities?" Dichotomous response of yes or no
6 years
Functional Capacity
Time Frame: 6 years
Self-reported physical capacity. A composite score of self-reported ability to do six pairs of activities: walking 3 or 6 blocks independently, climbing 10 or 20 stairs, lifting and carrying 10 or 20 pounds, bending over or kneeling down, reaching overhead or placing a heavy object overhead, and grasping small objects or opening a jar. Scores range 0-12 with higher scores indicating greater capacity to perform these activities.
6 years

Collaborators and Investigators

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

August 1, 2018

Primary Completion (ACTUAL)

July 31, 2020

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

April 27, 2021

First Posted (ACTUAL)

April 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data is publically available at https://www.nhats.org/

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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