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OpenTrials
Completed

NCT Number: NCT04864223

Classifying and Predicting Long-term Pain and Function 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bothersome Pain

    Time frame: 6 years

    Question: "In the last month, have you been bothered by pain?" Dichotomous response of yes or no

  2. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2021
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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