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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02380690
• Collaborator: (none)
• Enrollment: 215
• Location: 1
• Arms: 2
• Actual Duration (Months): 51
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: Peer Coach Assignment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 215 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE)
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer Coach Assignment Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.	Behavioral: Peer Coach Assignment; Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.
No Intervention: Control 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.

Outcome Measures

Primary Outcome Measures

1. Brief Pain Inventory (BPI) (Overall Pain Assessment) [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) [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 Outcome Measures

1. Pain Catastrophizing [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 [6 months]

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

3. Perceived Social Support [9 months]

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

4. Self Efficacy [6 months]

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

5. Self Efficacy [9 months]

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

6. Anxiety [6 months]

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

7. Anxiety [9 months]

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

8. Depression [6 months]

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

9. Depression [9 months]

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

10. Pain Catastrophizing [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 [6 months]

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

12. Patient Activation [9 months]

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

13. General Health Perceptions [6 months]

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

14. General Health Perceptions [9 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana	United States	46202-2884

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Marianne Sassi Matthias, PhD MS BA, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 1, 2015

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02380690
• Other Study ID Numbers: IIR 14-070; 1410626162
• First Posted: Mar 5, 2015
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by VA Office of Research and Development: self-management; peer support; social support
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Pre-assignment Detail	Two participants who enrolled withdrew prior to completing baseline assessments, leaving 119 randomized to the intervention and 94 to the control group.

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Period Title: Overall Study
STARTED	119	94
COMPLETED	85	82
NOT COMPLETED	34	12

Baseline Characteristics

Arm/Group Title	Peer Coach Assignment	Control	Total
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.	Total of all reporting groups
Overall Participants	119	94	213
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (12.6)	58.6 (13.3)	56.8 (13.0)
Sex: Female, Male (Count of Participants)
Female	24 20.2%	16 17%	40 18.8%
Male	95 79.8%	78 83%	173 81.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	28 23.5%	31 33%	59 27.7%
White	77 64.7%	55 58.5%	132 62%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	14 11.8%	8 8.5%	22 10.3%
Region of Enrollment (participants) [Number]
United States	119 100%	94 100%	213 100%
Brief Pain Inventory Total (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.8 (1.9)	5.8 (1.9)	5.8 (1.9)
Perceived Social Support (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	62.2 (16.5)	62.6 (18.1)	62.3 (17.2)
Self-Efficacy (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.1 (2.2)	6.2 (2.3)	6.1 (2.2)
Anxiety (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.1 (5.3)	6.2 (5.4)	6.1 (5.3)
Depression (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	9.3 (6.4)	8.9 (6.0)	9.2 (6.2)
Pain Catastrophizing (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.8 (13.1)	21.5 (13.3)	21.1 (13.2)
Patient Activation (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	60.6 (13.5)	57.9 (13.8)	59.4 (13.7)
General Health Perceptions (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	52.2 (20.9)	52.8 (21.1)	52.5 (21.0)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 were lost to follow up.

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	5.6 (2.0)	5.6 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments	ECLIPSE was powered to detect an effect size of 0.45.
Statistical Test of Hypothesis	p-Value	0.981
	Comments	Statistical significance was set at p<0.05
	Method	Regression, Linear
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 were lost to follow up.

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	5.4 (2.0)	5.3 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.774
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	21.8 (13.8)	22.0 (11.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments	Power was based on primary outcome.
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.546.
	Method	Regression, Linear
	Comments

4. Secondary Outcome

Title	Perceived Social Support
Description	Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 lost to follow up.

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	62.0 (17.9)	60.4 (16.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.403.
	Method	Regression, Linear
	Comments

5. Secondary Outcome

Title	Perceived Social Support
Description	Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 were lost to follow up.

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	63.6 (17.8)	62.1 (17.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.452.
	Method	Regression, Linear
	Comments

6. Secondary Outcome

Title	Self Efficacy
Description	Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	6.3 (2.3)	6.1 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.980
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.243.
	Method	Regression, Linear
	Comments

7. Secondary Outcome

Title	Self Efficacy
Description	Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	6.4 (2.2)	6.1 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.864
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.133.
	Method	Regression, Linear
	Comments

8. Secondary Outcome

Title	Anxiety
Description	GAD-7 (Range 0-21, higher numbers = higher anxiety)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	6.9 (5.4)	6.2 (4.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.780
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.102.
	Method	Regression, Linear
	Comments

9. Secondary Outcome

Title	Anxiety
Description	GAD-7 (Range 0-21, higher numbers = higher anxiety)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 lost to follow up.

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	6.5 (5.5)	6.4 (5.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.536.
	Method	Regression, Linear
	Comments

10. Secondary Outcome

Title	Depression
Description	PHQ-8 (Range: 0-24, higher numbers = higher depression)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	10.1 (6.7)	9.1 (5.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.997
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.340.
	Method	Regression, Linear
	Comments

11. Secondary Outcome

Title	Depression
Description	PHQ-8 (Range: 0-24, higher numbers = higher depression)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	9.2 (6.2)	8.3 (5.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.384.
	Method	Regression, Linear
	Comments

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	19.0 (13.5)	20.5 (12.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.730.
	Method	Regression, Linear
	Comments

13. Secondary Outcome

Title	Patient Activation
Description	Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	63.5 (14.9)	58.7 (14.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.914
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.161.
	Method	Regression, Linear
	Comments

14. Secondary Outcome

Title	Patient Activation
Description	Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 were lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	62.8 (14.7)	60.5 (14.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.930.
	Method	Regression, Linear
	Comments

15. Secondary Outcome

Title	General Health Perceptions
Description	SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

21 withdrew and 14 lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	92	86
Mean (Standard Deviation) [units on a scale]	52.7 (21.7)	50.1 (19.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.379.
	Method	Regression, Linear
	Comments

16. Secondary Outcome

Title	General Health Perceptions
Description	SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

7 withdrew and 4 were lost to follow up

Arm/Group Title	Peer Coach Assignment	Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Measure Participants	85	82
Mean (Standard Deviation) [units on a scale]	50.9 (21.5)	51.9 (21.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Coach Assignment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.999
	Comments	Statistical significance was set at p<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.969.
	Method	Regression, Linear
	Comments

Adverse Events

Time Frame	9 months
Arm/Group Title	Peer Coach Assignment		Control
Arm/Group Description	Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.		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.
All Cause Mortality
	Peer Coach Assignment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/94 (0%)
Serious Adverse Events
	Peer Coach Assignment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/94 (0%)
Other (Not Including Serious) Adverse Events
	Peer Coach Assignment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/94 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.