Trial Outcomes & Findings for Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (NCT NCT02380690)

NCT ID: NCT02380690

Last Updated: 2023-07-27

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 215 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-07-27

Participant Flow

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

Participant milestones

Measure	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. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Overall Study STARTED	119	94
Overall Study COMPLETED	85	82
Overall Study NOT COMPLETED	34	12

Reasons for withdrawal

Measure	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. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.	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.
Overall Study Lost to Follow-up	14	4
Overall Study Withdrawal by Subject	20	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Peer Coach Assignment n=119 Participants 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.	Control n=94 Participants 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 n=213 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 12.6 • n=5 Participants	58.6 years STANDARD_DEVIATION 13.3 • n=7 Participants	56.8 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	16 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants	78 Participants n=7 Participants	173 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	55 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	119 participants n=5 Participants	94 participants n=7 Participants	213 participants n=5 Participants
Brief Pain Inventory Total	5.8 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	5.8 units on a scale STANDARD_DEVIATION 1.9 • n=7 Participants	5.8 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants
Perceived Social Support	62.2 units on a scale STANDARD_DEVIATION 16.5 • n=5 Participants	62.6 units on a scale STANDARD_DEVIATION 18.1 • n=7 Participants	62.3 units on a scale STANDARD_DEVIATION 17.2 • n=5 Participants
Self-Efficacy	6.1 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	6.2 units on a scale STANDARD_DEVIATION 2.3 • n=7 Participants	6.1 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants
Anxiety	6.1 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants	6.2 units on a scale STANDARD_DEVIATION 5.4 • n=7 Participants	6.1 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants
Depression	9.3 units on a scale STANDARD_DEVIATION 6.4 • n=5 Participants	8.9 units on a scale STANDARD_DEVIATION 6.0 • n=7 Participants	9.2 units on a scale STANDARD_DEVIATION 6.2 • n=5 Participants
Pain Catastrophizing	20.8 units on a scale STANDARD_DEVIATION 13.1 • n=5 Participants	21.5 units on a scale STANDARD_DEVIATION 13.3 • n=7 Participants	21.1 units on a scale STANDARD_DEVIATION 13.2 • n=5 Participants
Patient Activation	60.6 units on a scale STANDARD_DEVIATION 13.5 • n=5 Participants	57.9 units on a scale STANDARD_DEVIATION 13.8 • n=7 Participants	59.4 units on a scale STANDARD_DEVIATION 13.7 • n=5 Participants
General Health Perceptions	52.2 units on a scale STANDARD_DEVIATION 20.9 • n=5 Participants	52.8 units on a scale STANDARD_DEVIATION 21.1 • n=7 Participants	52.5 units on a scale STANDARD_DEVIATION 21.0 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 were lost to follow up.

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)

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
Brief Pain Inventory (BPI) (Overall Pain Assessment)	5.6 units on a scale Standard Deviation 2.0	5.6 units on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 were lost to follow up.

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)

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
Brief Pain Inventory (BPI) (Overall Pain Assessment)	5.4 units on a scale Standard Deviation 2.0	5.3 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 lost to follow up

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)

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
Pain Catastrophizing	21.8 units on a scale Standard Deviation 13.8	22.0 units on a scale Standard Deviation 11.8

SECONDARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 lost to follow up.

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

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
Perceived Social Support	62.0 units on a scale Standard Deviation 17.9	60.4 units on a scale Standard Deviation 16.4

SECONDARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 were lost to follow up.

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

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
Perceived Social Support	63.6 units on a scale Standard Deviation 17.8	62.1 units on a scale Standard Deviation 17.3

SECONDARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
Self Efficacy	6.3 units on a scale Standard Deviation 2.3	6.1 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
Self Efficacy	6.4 units on a scale Standard Deviation 2.2	6.1 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
Anxiety	6.9 units on a scale Standard Deviation 5.4	6.2 units on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 lost to follow up.

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

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
Anxiety	6.5 units on a scale Standard Deviation 5.5	6.4 units on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
Depression	10.1 units on a scale Standard Deviation 6.7	9.1 units on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
Depression	9.2 units on a scale Standard Deviation 6.2	8.3 units on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 lost to follow up

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)

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
Pain Catastrophizing	19.0 units on a scale Standard Deviation 13.5	20.5 units on a scale Standard Deviation 12.4

SECONDARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
Patient Activation	63.5 units on a scale Standard Deviation 14.9	58.7 units on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 were lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
Patient Activation	62.8 units on a scale Standard Deviation 14.7	60.5 units on a scale Standard Deviation 14.9

SECONDARY outcome

Timeframe: 6 months

Population: 21 withdrew and 14 lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=92 Participants 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.	Control n=86 Participants 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.
General Health Perceptions	52.7 units on a scale Standard Deviation 21.7	50.1 units on a scale Standard Deviation 19.7

SECONDARY outcome

Timeframe: 9 months

Population: 7 withdrew and 4 were lost to follow up

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

Outcome measures

Measure	Peer Coach Assignment n=85 Participants 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.	Control n=82 Participants 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.
General Health Perceptions	50.9 units on a scale Standard Deviation 21.5	51.9 units on a scale Standard Deviation 21.0

Adverse Events

Peer Coach Assignment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert O'Brien

VA ORD

Phone: 2024435741

Email: Robert.O'Brien2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place