NCT02380690

Brief Summary

To maximize implementation potential of pain self-management in the VA, alternative delivery methods are needed to provide Veterans with education and support needed to self-manage their pain, without requiring additional resources from healthcare teams. A novel and promising approach is a peer coaching model, in which Veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other Veterans with pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable chronic-pain

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

First Submitted

Initial submission to the registry

February 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 17, 2020

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4.3 years

First QC Date

February 23, 2015

Results QC Date

July 2, 2020

Last Update Submit

July 19, 2023

Conditions

Chronic Pain

Keywords

self-managementpeer supportsocial support

Outcome Measures

Primary Outcomes (2)

  • Brief Pain Inventory (BPI) (Overall Pain Assessment)

    The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable)

    6 months

  • Brief Pain Inventory (BPI) (Overall Pain Assessment)

    The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable)

    9 months

Secondary Outcomes (14)

  • Pain Catastrophizing

    6 months

  • Perceived Social Support

    6 months

  • Perceived Social Support

    9 months

  • Self Efficacy

    6 months

  • Self Efficacy

    9 months

  • +9 more secondary outcomes

Study Arms (2)

Peer Coach Assignment

EXPERIMENTAL

Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.

Behavioral: Peer Coach Assignment

Control

NO INTERVENTION

Veteran participants will attend a 2-hour class in pain "basics" and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management.

Interventions

Peer Coach AssignmentBEHAVIORAL

Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.

Peer Coach Assignment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for 3 months
  • have at least moderate pain severity, defined by pain 5 on a 0 (no pain) to 10 (worst pain imaginable) scale
  • indicate willingness to engage in phone or in-person contact on a regular basis with another Veteran

You may not qualify if:

  • if the electronic medical record indicates a diagnosis of a psychotic disorder (e.g., International Classification of Diseases (ICD) ICD-9 codes 295-295.9 for schizophrenia)
  • current substance dependence (e.g., ICD-9 codes 304-304.9)
  • severe medical conditions precluding participation (e.g., New York Heart Association Class III or IV heart failure, ICD-9 codes 428-428.9 )
  • if the eligibility screener given to prospective participants reveals active suicidal ideation severe hearing or speech impairment
  • pending surgery for a musculoskeletal condition (e.g., back surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (5)

  • Matthias MS, Daggy J, Adams J, Menen T, McCalley S, Kukla M, McGuire AB, Ofner S, Pierce E, Kempf C, Heisler M, Bair MJ. Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics. Contemp Clin Trials. 2019 Jun;81:71-79. doi: 10.1016/j.cct.2019.04.002. Epub 2019 Apr 2.

    PMID: 30951837RESULT

  • Shue SA, McGuire AB, Matthias MS. Facilitators and Barriers to Implementation of a Peer Support Intervention for Patients with Chronic Pain: A Qualitative Study. Pain Med. 2019 Jul 1;20(7):1311-1320. doi: 10.1093/pm/pny229.

    PMID: 30481295RESULT

  • Matthias MS, Daggy J, Ofner S, McGuire AB, Kukla M, Bair MJ. Exploring peer coaches' outcomes: Findings from a clinical trial of patients with chronic pain. Patient Educ Couns. 2020 Jul;103(7):1366-1372. doi: 10.1016/j.pec.2020.02.007. Epub 2020 Feb 5.

    PMID: 32044190RESULT

  • Matthias MS, Bair MJ, Ofner S, Heisler M, Kukla M, McGuire AB, Adams J, Kempf C, Pierce E, Menen T, McCalley S, Johnson NL, Daggy J. Peer Support for Self-Management of Chronic Pain: the Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE) Trial. J Gen Intern Med. 2020 Dec;35(12):3525-3533. doi: 10.1007/s11606-020-06007-6. Epub 2020 Jul 22.

    PMID: 32700220RESULT

  • Matthias MS, Hirsh AT, Ofner S, Daggy J. Exploring the Relationships Among Social Support, Patient Activation, and Pain-Related Outcomes. Pain Med. 2022 Apr 8;23(4):676-685. doi: 10.1093/pm/pnab306.

    PMID: 34718764DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Robert O'Brien
Organization
VA ORD
Robert.O'Brien2@va.gov
2024435741

Study Officials

  • Marianne Sassi Matthias, PhD MS BA

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 5, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

July 27, 2023

Results First Posted

August 17, 2020

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data will become available once the study team completes all analyses.
Access Criteria
The Research Service will evaluate individual requests.

Locations

US(1)