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Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Coach Assignment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring self-management, peer support, social support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer Coach Assignment

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Pain Catastrophizing
Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)
Perceived Social Support
Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Perceived Social Support
Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Self Efficacy
Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Self Efficacy
Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Anxiety
GAD-7 (Range 0-21, higher numbers = higher anxiety)
Anxiety
GAD-7 (Range 0-21, higher numbers = higher anxiety)
Depression
PHQ-8 (Range: 0-24, higher numbers = higher depression)
Depression
PHQ-8 (Range: 0-24, higher numbers = higher depression)
Pain Catastrophizing
Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)
Patient Activation
Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
Patient Activation
Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
General Health Perceptions
SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)
General Health Perceptions
SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)

Full Information

First Posted
February 23, 2015
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02380690
Brief Title
Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms
Acronym
ECLIPSE
Official Title
Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators' goal is to test the effectiveness of a peer coaching model among Veterans. The investigators are examining feasibility for implementation alongside effectiveness, to shorten the timeline to implementation. Aim 1 (primary aim): To compare 6-month (primary endpoint) and 9-month (sustained effects) effects of peer-supported chronic pain self-management versus controls on overall pain (intensity and function). Hypothesis 1: Veterans in the peer support arm will experience reduced overall pain compared to controls. Aim 2 (secondary aim): To compare 6- and 9-month effects of peer-supported chronic pain self-management versus controls on self-efficacy, social support, pain coping, patient activation, health-related quality of life, and health service utilization. Hypothesis 2: Veterans in the peer support arm will experience greater self-efficacy, social support, pain coping, patient activation, and health-related quality of life, and lower health service utilization, compared to controls. Aim 3 (pre-implementation aim): To explore facilitators and barriers to implementation of peer support for chronic pain, intervention costs, and fidelity to the model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
self-management, peer support, social support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Coach Assignment
Arm Type
Experimental
Arm Description
Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Coach Assignment
Intervention Description
Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI) (Overall Pain Assessment)
Description
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)
Time Frame
6 months
Title
Brief Pain Inventory (BPI) (Overall Pain Assessment)
Description
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)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)
Time Frame
6 months
Title
Perceived Social Support
Description
Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Time Frame
6 months
Title
Perceived Social Support
Description
Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Time Frame
9 months
Title
Self Efficacy
Description
Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Time Frame
6 months
Title
Self Efficacy
Description
Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Time Frame
9 months
Title
Anxiety
Description
GAD-7 (Range 0-21, higher numbers = higher anxiety)
Time Frame
6 months
Title
Anxiety
Description
GAD-7 (Range 0-21, higher numbers = higher anxiety)
Time Frame
9 months
Title
Depression
Description
PHQ-8 (Range: 0-24, higher numbers = higher depression)
Time Frame
6 months
Title
Depression
Description
PHQ-8 (Range: 0-24, higher numbers = higher depression)
Time Frame
9 months
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)
Time Frame
9 months
Title
Patient Activation
Description
Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
Time Frame
6 months
Title
Patient Activation
Description
Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
Time Frame
9 months
Title
General Health Perceptions
Description
SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)
Time Frame
6 months
Title
General Health Perceptions
Description
SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Sassi Matthias, PhD MS BA
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will become available once the study team completes all analyses.
IPD Sharing Access Criteria
The Research Service will evaluate individual requests.
Citations:
PubMed Identifier
30951837
Citation
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.
Results Reference
result
PubMed Identifier
30481295
Citation
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.
Results Reference
result
PubMed Identifier
32044190
Citation
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.
Results Reference
result
PubMed Identifier
32700220
Citation
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.
Results Reference
result
PubMed Identifier
34718764
Citation
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.
Results Reference
derived

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Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms

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