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

• ClinicalTrials.gov Identifier: NCT04864223
• Recruitment Status: Completed
• First Posted: April 28, 2021
• Last Update Posted: April 28, 2021
• Sponsor: University of Washington
• Collaborator: University of Pittsburgh
• Information provided by (Responsible Party): Sean Rundell, University of Washington

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
Chronic Pain; Pain

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: August 1, 2018
• Actual Primary Completion Date: July 31, 2020
• Actual Study Completion Date: July 31, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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

United States, Washington

University of Washington

Seattle, Washington, United States, 98105

Sponsors and Collaborators

University of Washington

University of Pittsburgh

More Information

• Responsible Party: Sean Rundell, Assistant Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT04864223
• Other Study ID Numbers: STUDY00005507
• First Posted: April 28, 2021
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data is publically available at https://www.nhats.org/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sean Rundell, University of Washington:

older adults; chronic pain; function; physical performance

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations