NCT05681520

Brief Summary

Chronic non-cancer pain is common among Veterans, and more work is needed to understand how best to support Veterans with chronic pain to improve pain-related function and quality of life. Peer specialists may be valuable resource to support Veterans in pain management. Peer specialists, individuals with lived experience who are hired and trained to work with Veterans, are increasingly being used outside traditional mental health settings. More research is needed to understand how best to train peer specialists to work in new settings and with new presenting problems, such as chronic pain. Peer support to help Veterans improve pain-related function, increase physical activity, and engage in recommended pain care, is especially needed. In this study, the investigators will finalize a peer-led intervention and then pilot it with 24 Veterans with chronic pain in order to establish feasibility and acceptability; results will be used to develop a larger proposal testing the intervention in a randomized trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2023

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

December 16, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

December 16, 2022

Last Update Submit

January 24, 2025

Conditions

Keywords

chronic painpeer support

Outcome Measures

Primary Outcomes (2)

  • Feasibility - Number of completers

    Number of Veterans who completed at least 3 sessions with the peer specialist

    through study completion, approximately 18 months

  • Acceptability

    Intervention acceptability as indicated by results of qualitative interviews

    3 months

Secondary Outcomes (4)

  • Feasibility - Recruiting 24 participants

    through study completion, approximately 18 months

  • Feasibility - Enrollment of >15% of those invited

    through study completion, approximately 18 months

  • Feasibility - Retention >60%

    through study completion, approximately 18 months

  • Acceptability - Quantitative

    3 months

Other Outcomes (6)

  • Pain Interference

    3 months

  • Physical Function

    3 months

  • Well-being

    3 months

  • +3 more other outcomes

Study Arms (1)

peer specialist

EXPERIMENTAL

Work with a peer specialist for six 30-minute sessions

Behavioral: PEEPS

Interventions

PEEPSBEHAVIORAL

Working with a peer specialist for six 30-minute sessions to enhance engagement in pain management approaches/treatments

Also known as: Peer Specialist Intervention
peer specialist

Eligibility Criteria

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

You may qualify if:

  • Veteran receiving care from VA Connecticut Healthcare System
  • referred to a VA Connecticut Pain Management Team
  • has high-impact chronic pain as defined by the Graded Chronic Pain Scale - Revised
  • willing/able to participate in sessions either in person or via video

You may not qualify if:

  • moderate to severe cognitive impairment or apparent difficulty communicating with the research staff
  • inability to read or understand English
  • severely impaired hearing or speech that would preclude them from participating in telephone interviews

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sara Edmond, PhD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single arm pilot study; intervention includes six 30-minute sessions with a peer specialist
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 12, 2023

Study Start

April 10, 2023

Primary Completion

October 1, 2024

Study Completion

December 31, 2024

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

A de-identified, anonymized dataset will be created and shared. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication by contacting the study PI. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will become available within 1 year of publication. The analytical datasets and statistical code used in the publication will be retained for 6 years, in accordance with VA record retention policy.
Access Criteria
Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement. De-identified data will be provided after requesters sign a Letter of Agreement detailing the mechanisms by which the data will be kept secure and access restricted to their study team and will state that the recipient will not attempt to identify any individual whose data are included and will not share the data.

Locations