Trial Outcomes & Findings for IMproving Pain Using Peer RE-inforced Self-management Skills (NCT NCT01748227)

Results Overview

3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Change from baseline to 4 month assessment

Results posted on

2015-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Pain Self-Management Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IMproving Pain Using Peer RE-inforced Self-management Skills

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Self-Management n=17 Participants Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	58 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: Change from baseline to 4 month assessment

3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.

Outcome measures

Outcome measures
Measure	Pain Self-Management n=17 Participants Peer delivery of pain self-management to veterans Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies.
Pain/Enjoyment of Life/General Activity	-1.24 units on a scale Standard Deviation 4.60

SECONDARY outcome

Timeframe: Baseline and 4 month assessment (final assessment)

Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.

Outcome measures

Outcome measures
Measure	Pain Self-Management n=17 Participants Peer delivery of pain self-management to veterans Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies.
Pain Catastrophizing Scale	-5.12 units on a scale Standard Deviation 12.93

SECONDARY outcome

Timeframe: Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance

12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).

Outcome measures

Outcome measures
Measure	Pain Self-Management n=17 Participants Peer delivery of pain self-management to veterans Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies.
Multidimensional Perceived Social Support Scale (MPSS).	6.96 units on a scale Standard Deviation 16.60

SECONDARY outcome

Timeframe: Change from baseline to 4 month assessment

Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.

Outcome measures

Outcome measures
Measure	Pain Self-Management n=17 Participants Peer delivery of pain self-management to veterans Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies.
Patient Reported Outcome Measurement System (PROMIS)	-4.18 units on a scale Standard Deviation 11.39

SECONDARY outcome

Timeframe: 4 month assessment

Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.

Outcome measures

Outcome measures
Measure	Pain Self-Management n=17 Participants Peer delivery of pain self-management to veterans Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies.
Pain Centrality Scale	-5.29 units on a scale Standard Deviation 8.79

Adverse Events

Pain Self-Management

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

Dr. Marianne Matthias

Richard L. Roudebush VAMC HSR&D

Phone: 317-988-4514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place