NCT04864223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,783

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

August 14, 2019

Last Update Submit

April 27, 2021

Conditions

Keywords

older adultschronic painfunctionphysical performance

Outcome Measures

Primary Outcomes (2)

  • Bothersome Pain

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

    6 years

  • 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 Outcomes (2)

  • Activity Limitations Due to Pain

    6 years

  • Functional Capacity

    6 years

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • community-dwelling older adults from Round 1 of the NHATS cohort

You may not qualify if:

  • participants who are non-ambulatory (require a wheelchair or scooter for mobility) at Round 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2019

First Posted

April 28, 2021

Study Start

August 1, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Data is publically available at https://www.nhats.org/

Locations