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

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT04864223
Collaborator
University of Pittsburgh (Other)
6,783
1
24
282.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    6783 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A New Approach to Classifying and Predicting Long-term Bothersome Pain and Functional Decline in Older Adults
    Actual Study Start Date :
    Aug 1, 2018
    Actual Primary Completion Date :
    Jul 31, 2020
    Actual Study Completion Date :
    Jul 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Bothersome Pain [6 years]

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

    2. Physical Performance [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 Outcome Measures

    1. Activity Limitations Due to Pain [6 years]

      Question: "In the last month, has pain ever limited your activities?" Dichotomous response of yes or no

    2. Functional Capacity [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Washington Seattle Washington United States 98105

    Sponsors and Collaborators

    • University of Washington
    • University of Pittsburgh

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sean Rundell, Assistant Professor, University of Washington
    ClinicalTrials.gov Identifier:
    NCT04864223
    Other Study ID Numbers:
    • STUDY00005507
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sean Rundell, Assistant Professor, University of Washington
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2021