NCT01748227

Brief Summary

The overall purpose of this pilot study is to conduct a formative evaluation of (veteran)peer delivery of a chronic pain self-management program to veterans with chronic musculoskeletal pain. Our specific aims are as follows: Aim 1: Evaluate the feasibility of identifying, recruiting, training, and retaining veteran peers to implement a self-management program for chronic pain. Aim 2: Identify facilitators and barriers to peer-delivery of a chronic pain self-management program. Aim 3: Convene an expert panel to review the results of Aims 1 and 2, help to interpret the results, and plan next steps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2013

Shorter than P25 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

November 21, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 19, 2015

Completed
Last Updated

May 15, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

November 21, 2012

Results QC Date

December 11, 2014

Last Update Submit

April 27, 2015

Conditions

Keywords

self-managementpeer supportsocial support

Outcome Measures

Primary Outcomes (1)

  • Pain/Enjoyment of Life/General Activity

    3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.

    Change from baseline to 4 month assessment

Secondary Outcomes (4)

  • Pain Catastrophizing Scale

    Baseline and 4 month assessment (final assessment)

  • Multidimensional Perceived Social Support Scale (MPSS).

    Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance

  • Patient Reported Outcome Measurement System (PROMIS)

    Change from baseline to 4 month assessment

  • Pain Centrality Scale

    4 month assessment

Study Arms (1)

Peer-Coached Pain Self-Management

OTHER

Participants (n=20) were assigned to a peer coach, who delivered self-management instruction one-on-one over a 4-month period.

Behavioral: Peer-Delivered Pain Self-Management

Interventions

Patients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management.

Peer-Coached Pain Self-Management

Eligibility Criteria

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

You may qualify if:

  • Peers will be eligible if they have chronic musculoskeletal pain and have completed a pain self-management program from any of these chronic pain trials:
  • Stepped Care for Depression and Musculoskeletal Pain (SCAMP)
  • Evaluation of Stepped Care for Chronic Pain in Iraq and Afghanistan Veterans (ESCAPE)
  • CAre Management for the Effective use of Opioids (CAMEO)
  • Or participants of the VA Pain School or VA Pain program
  • Peers may also be recommended by their primary care providers at the VA
  • Eligible patients must have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) that has persisted for 3 months
  • And have pain of at least moderate intensity as defined by a Brief Pain Inventory score 5

You may not qualify if:

  • Patients will be excluded if they have active suicidal ideation
  • Have been hospitalized for psychiatric or substance abuse reasons in the last 6 months pending back surgery
  • Current substance dependence
  • Severe medical conditions (e.g., New York Heart Association Class III or IV heart failure) that precludes participation
  • Or severe hearing or speech impairment

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 (4)

  • Matthias MS, McGuire AB, Kukla M, Daggy J, Myers LJ, Bair MJ. A brief peer support intervention for veterans with chronic musculoskeletal pain: a pilot study of feasibility and effectiveness. Pain Med. 2015 Jan;16(1):81-7. doi: 10.1111/pme.12571. Epub 2014 Oct 14.

  • Matthias MS, Kukla ME, McGuire AB, Bair MJ. Peer support for chronic pain self-management: A qualitative study of peer coaches' experiences. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):169-170.

    RESULT
  • Matthias MS, McGuire AB, Kukla ME, Daggy J, Myers L, Bair MJ. Effectiveness of a brief peer support intervention for veterans with chronic pain. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):80.

    RESULT
  • Matthias MS, Kukla M, McGuire AB, Bair MJ. How Do Patients with Chronic Pain Benefit from a Peer-Supported Pain Self-Management Intervention? A Qualitative Investigation. Pain Med. 2016 Dec;17(12):2247-2255. doi: 10.1093/pm/pnw138. Epub 2016 Jul 8.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pilot study to examine feasibility and preliminary effectiveness of peer support for veterans with chronic pain. Because of the small sample size and pretest/posttest design of the study, results should be interpreted with caution.

Results Point of Contact

Title
Dr. Marianne Matthias
Organization
Richard L. Roudebush VAMC HSR&D

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
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

December 12, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

May 15, 2015

Results First Posted

March 19, 2015

Record last verified: 2015-04

Locations