NCT03945877

Brief Summary

A mixed-methods sequential explanatory design study. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. The second qualitative phase will use focus group will elucidate, confirm, and more richly describe the findings from the first phase.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

3.9 years

First QC Date

May 9, 2019

Last Update Submit

July 29, 2020

Conditions

Chronic PainMarginalization, Social

Outcome Measures

Primary Outcomes (2)

  • Quantitative: Community surveys

    Demographic data; Survey data

    February 2017-September 2017

  • Qualitative: Focus groups

    Semi-structured interview data obtained from focus groups

    November 2018-December 2019

Study Arms (3)

English-speaking Community Members

Survey respondents

Other: No interventions

Spanish-speaking Community Members

Survey respondents

Other: No interventions

Arabic-speaking Community Members

Survey respondents

Other: No interventions

Interventions

No interventionsOTHER

No interventions

Arabic-speaking Community MembersEnglish-speaking Community MembersSpanish-speaking Community Members

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

English-speaking adults who answer the phone and consent to participate. Spanish and Arabic-speaking adults who consent to participate in an in-person survey.

You may qualify if:

  • English, Spanish, and Arabic-speaking adults living in the Piedmont Triad, NC

You may not qualify if:

  • declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Point University

High Point, North Carolina, 27282, United States

RECRUITING

Related Publications (13)

  • Mansfield KE, Sim J, Jordan JL, Jordan KP. A systematic review and meta-analysis of the prevalence of chronic widespread pain in the general population. Pain. 2016 Jan;157(1):55-64. doi: 10.1097/j.pain.0000000000000314.

    PMID: 26270591BACKGROUND

  • Macfarlane GJ, Barnish MS, Jones GT. Persons with chronic widespread pain experience excess mortality: longitudinal results from UK Biobank and meta-analysis. Ann Rheum Dis. 2017 Nov;76(11):1815-1822. doi: 10.1136/annrheumdis-2017-211476. Epub 2017 Jul 21.

    PMID: 28733474BACKGROUND

  • Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain. 2009 May;10(5):447-85. doi: 10.1016/j.jpain.2008.12.001.

    PMID: 19411059BACKGROUND

  • Pedraza FI, Nichols VC, LeBron AMW. Cautious Citizenship: The Deterring Effect of Immigration Issue Salience on Health Care Use and Bureaucratic Interactions among Latino US Citizens. J Health Polit Policy Law. 2017 Oct;42(5):925-960. doi: 10.1215/03616878-3940486. Epub 2017 Jun 29.

    PMID: 28663179BACKGROUND

  • Edwards RR, Moric M, Husfeldt B, Buvanendran A, Ivankovich O. Ethnic similarities and differences in the chronic pain experience: a comparison of african american, Hispanic, and white patients. Pain Med. 2005 Jan-Feb;6(1):88-98. doi: 10.1111/j.1526-4637.2005.05007.x.

    PMID: 15669954BACKGROUND

  • Kim HJ, Yang GS, Greenspan JD, Downton KD, Griffith KA, Renn CL, Johantgen M, Dorsey SG. Racial and ethnic differences in experimental pain sensitivity: systematic review and meta-analysis. Pain. 2017 Feb;158(2):194-211. doi: 10.1097/j.pain.0000000000000731.

    PMID: 27682208BACKGROUND

  • Green CR, Anderson KO, Baker TA, Campbell LC, Decker S, Fillingim RB, Kalauokalani DA, Lasch KE, Myers C, Tait RC, Todd KH, Vallerand AH. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003 Sep;4(3):277-94. doi: 10.1046/j.1526-4637.2003.03034.x.

    PMID: 12974827BACKGROUND

  • Trost Z, Van Ryckeghem D, Scott W, Guck A, Vervoort T. The Effect of Perceived Injustice on Appraisals of Physical Activity: An Examination of the Mediating Role of Attention Bias to Pain in a Chronic Low Back Pain Sample. J Pain. 2016 Nov;17(11):1207-1216. doi: 10.1016/j.jpain.2016.08.001. Epub 2016 Aug 20.

    PMID: 27555428BACKGROUND

  • Craig KD. Social communication model of pain. Pain. 2015 Jul;156(7):1198-1199. doi: 10.1097/j.pain.0000000000000185. No abstract available.

    PMID: 26086113BACKGROUND

  • Harding G, Parsons S, Rahman A, Underwood M. "It struck me that they didn't understand pain": the specialist pain clinic experience of patients with chronic musculoskeletal pain. Arthritis Rheum. 2005 Oct 15;53(5):691-6. doi: 10.1002/art.21451.

    PMID: 16208656BACKGROUND

  • Franklin ZC, Smith NC, Fowler NE. A qualitative investigation of factors that matter to individuals in the pain management process. Disabil Rehabil. 2016 Sep;38(19):1934-42. doi: 10.3109/09638288.2015.1107782. Epub 2016 Jan 4.

    PMID: 26728636BACKGROUND

  • Burgess DJ, van Ryn M, Crowley-Matoka M, Malat J. Understanding the provider contribution to race/ethnicity disparities in pain treatment: insights from dual process models of stereotyping. Pain Med. 2006 Mar-Apr;7(2):119-34. doi: 10.1111/j.1526-4637.2006.00105.x.

    PMID: 16634725BACKGROUND

  • Klonoff EA. Disparities in the provision of medical care: an outcome in search of an explanation. J Behav Med. 2009 Feb;32(1):48-63. doi: 10.1007/s10865-008-9192-1. Epub 2009 Jan 6.

    PMID: 19127421BACKGROUND

MeSH Terms

Conditions

Chronic PainSocial Marginalization

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Officials

  • Alicia Emerson, PT, DPT, MS

    High Point University and University of Otago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Emerson, PT, DPT, MS

CONTACT

336-841-9726aemerson1@highpoint.edu

Study Design

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

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 10, 2019

Study Start

February 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)