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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864223
• Other study ID #: STUDY00005507
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6783
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bothersome Pain	Question: "In the last month, have you been bothered by pain?" Dichotomous response of yes or no	6 years
Primary	Physical Performance	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	Activity Limitations Due to Pain	Question: "In the last month, has pain ever limited your activities?" Dichotomous response of yes or no	6 years
Secondary	Functional Capacity	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