- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864223
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
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Washington
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Seattle, Washington, United States, 98105
- University of Washington
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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 |
|---|---|---|
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Bothersome Pain
Time Frame: 6 years
|
Question: "In the last month, have you been bothered by pain?" Dichotomous response of yes or no
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6 years
|
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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
|
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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.
Sponsor
Collaborators
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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