AzTrials
AzTrials

Chronic PainECLIPSENCT02380690

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

A study testing Peer Coach Assignment in people with Chronic Pain, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Peer Coach Assignment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
1 siteUnited States
Study dates
1 May 2015to 1 Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Chronic Pain
Being tested
Peer Coach Assignment
Keywords
self-management, peer support, social support
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer Coach AssignmentBehavioural

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

Study groups in NCT02380690
Study groupRoleWhat they receive
Peer Coach AssignmentExperimentalVeteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.
Receives: Behavioral: Peer Coach Assignment
ControlNo interventionVeteran 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 months

  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)

    Measured: 9 months

Secondary outcomes (14)

  1. 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)

    Measured: 6 months

  2. Perceived Social Support

    Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)

    Measured: 6 months

  3. Perceived Social Support

    Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)

    Measured: 9 months

  4. Self Efficacy

    Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)

    Measured: 6 months

  5. Self Efficacy

    Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)

    Measured: 9 months

  6. Anxiety

    GAD-7 (Range 0-21, higher numbers = higher anxiety)

    Measured: 6 months

  7. Anxiety

    GAD-7 (Range 0-21, higher numbers = higher anxiety)

    Measured: 9 months

  8. Depression

    PHQ-8 (Range: 0-24, higher numbers = higher depression)

    Measured: 6 months

  9. Depression

    PHQ-8 (Range: 0-24, higher numbers = higher depression)

    Measured: 9 months

  10. 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)

    Measured: 9 months

  11. Patient Activation

    Patient Activation Measure (Range: 0-100, higher numbers = higher activation)

    Measured: 6 months

  12. Patient Activation

    Patient Activation Measure (Range: 0-100, higher numbers = higher activation)

    Measured: 9 months

  13. General Health Perceptions

    SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)

    Measured: 6 months

  14. General Health Perceptions

    SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study start1 May 2015
  3. Primary completion1 Aug 2019
  4. Study completion1 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02380690
Sponsor's protocol ID
IIR 14-070
Other IDs
1410626162
Acronym
ECLIPSE
Status last verified
Jul 2023
First submitted
23 Feb 2015
Last updated
27 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30951837

  • 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.

    PubMed 30481295

  • 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.

    PubMed 32044190

  • 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.

    PubMed 32700220

  • 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.

    PubMed 34718764

Questions about this trial

What is this clinical trial studying?

A study testing Peer Coach Assignment in people with Chronic Pain, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory (BPI) (Overall Pain Assessment) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02380690, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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