Chronic PainNCT04864223
Classifying and Predicting Long-term Pain and Function in Older Adults
An observational study of Chronic Pain and Pain, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Pain
- How many people
- 6,783 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- community-dwelling older adults from Round 1 of the NHATS cohort
Who cannot join
- participants who are non-ambulatory (require a wheelchair or scooter for mobility) at Round 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Pain
- Keywords
- older adults, chronic pain, function, physical performance
- Medical subject headings
- Chronic Pain, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Bothersome Pain
Question: "In the last month, have you been bothered by pain?" Dichotomous response of yes or no
Measured: 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
Measured: 6 years
Secondary outcomes (2)
Activity Limitations Due to Pain
Question: "In the last month, has pain ever limited your activities?" Dichotomous response of yes or no
Measured: 6 years
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Aug 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,783 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Sean Rundell, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864223
- Sponsor's protocol ID
- STUDY00005507
- Status last verified
- Apr 2021
- First submitted
- 14 Aug 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is publically available at https://www.nhats.org/
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Classifying and Predicting Long-term Bothersome Pain and Functional Decline in Older Adults
- ClinicalTrials.gov ID
- NCT04864223
- Acronym / sponsor ID
- STUDY00005507
- Conditions
- Chronic Pain, Pain
- Keywords
- older adults, chronic pain, function, physical performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,783 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- community-dwelling older adults from Round 1 of the NHATS cohort
Key exclusion criteria (1 listed)
- participants who are non-ambulatory (require a wheelchair or scooter for mobility) at Round 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bothersome Pain
Time frame: 6 years
Question: "In the last month, have you been bothered by pain?" Dichotomous response of yes or no
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
2 secondary outcomes
Activity Limitations Due to Pain
Time frame: 6 years
Functional Capacity
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Yes. Data is publically available at https://www.nhats.org/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Pain, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bothersome Pain (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.