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Completed

NCT Number: NCT02380690

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Peer Coach Assignment

Behavioral

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

Primary outcomes

  1. Brief Pain Inventory (BPI) (Overall Pain Assessment)

    Time frame: 6 months

    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)

  2. Brief Pain Inventory (BPI) (Overall Pain Assessment)

    Time frame: 9 months

    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 outcomes

  1. Pain Catastrophizing

    Time frame: 6 months

    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)

  2. Perceived Social Support

    Time frame: 6 months

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

  3. Perceived Social Support

    Time frame: 9 months

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

  4. Self Efficacy

    Time frame: 6 months

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

  5. Self Efficacy

    Time frame: 9 months

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

  6. Anxiety

    Time frame: 6 months

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

  7. Anxiety

    Time frame: 9 months

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

  8. Depression

    Time frame: 6 months

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

  9. Depression

    Time frame: 9 months

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

  10. Pain Catastrophizing

    Time frame: 9 months

    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)

  11. Patient Activation

    Time frame: 6 months

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

  12. Patient Activation

    Time frame: 9 months

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

  13. General Health Perceptions

    Time frame: 6 months

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

  14. General Health Perceptions

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: ECLIPSE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2015
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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