ACTION: A Proactive Walking Trial to Reduce Pain in Black Veterans

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01983228
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.9
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief Summary

The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Pain	Behavioral: Intervention Condition	N/A

Detailed Description

BACKGROUND/RATIONALE:

Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans, affecting approximately 60% of those seen in VA primary care. Although perceived effectiveness of chronic pain treatment is low among all VA patients, black patients are less likely than whites to perceive their treatment as effective, and are more likely to experience functional limitations due to pain. There is growing consensus that chronic pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental contributors to pain, some of which differ by race and hence contribute to disparities. For example, blacks experience greater pain-related fear and lower self-efficacy in coping with pain (psychological contributors), and neighborhoods that make physical activity difficult (environmental contributors). However, there is a lack of effective interventions to improve pain treatment among minority patients, particularly those that target psychological and environmental contributors.

OBJECTIVES:

The long term goal is to improve the quality and equity of pain treatment in order to improve pain outcomes for all Veterans. The objective of this application is to test the effectiveness of a multi-component intervention that specifically targets known barriers to effective pain care among black Veterans with chronic MSK pain. The primary hypothesis is that a telephone-delivered intervention, which emphasizes walking and incorporates Action Planning, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques, and the use of pedometers, will improve core chronic pain outcomes in black Veterans. Secondarily, we will determine whether our intervention also benefits non-black patients with MSK.

METHODS:

The investigators propose a randomized trial to test the effectiveness of the intervention compared with usual care (UC) among 500 patients with chronic MSK pain, with a minimum of 250 Black participants. Patients from the Atlanta VAMC will be identified using administrative data. Patients will be screened by phone, and, if eligible, will be mailed the baseline survey to complete and mail back. Eligible patients who complete the baseline survey will be randomly assigned to the usual care (UC) or intervention condition (IC). Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months. Patients in the UC condition will receive an informational brochure and a pedometer. The study is powered to find a difference between the IC and UC groups within the black and non-black groups. The primary outcome is chronic pain-related physical functioning, assessed by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining potential mediators targeted by the intervention, exploring whether the intervention affects service utilization and use of opioid analgesics, and exploring whether the intervention reduces racial disparities in pain outcomes. Measures will be assessed by mail and phone survey at baseline, 3 months, and 6 months. Data analysis of primary aims will follow intent-to-treat methodology.

FINDINGS:

None at this time.

STATUS:

Focus groups were conducted at the Atlanta VAMC in September and October 2015. These focus groups provided valuable information that led us to refine our recruitment materials. Focus groups also yielded important information for our counselors, including potential communication barriers and barriers to walking. During January - April 2016, we conducted a pilot test of our intervention with 3 participants. We began the trial on July 2016. Recruitment and randomization were completed in June 2019. The intervention activities were completed in September 2019. Follow-up survey data collection is currently ongoing.

IMPACT:

The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking.

Study Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months.Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months.
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Proactive Walking Trial to Reduce Pain in Black Veterans
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Feb 27, 2020
• Actual Study Completion Date: Feb 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Arm 1: Usual Care Participants randomized to the usual care control condition will receive pedometers and an informational brochure.
Experimental: Arm 2: Intervention Group Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.	Behavioral: Intervention Condition; Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.

Outcome Measures

Primary Outcome Measures

1. 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months [Assessed at baseline and 6 months]

   30% improvement on the Roland Morris Disability Questionnaire [RMDQ]) from baseline over the 6-month follow-up period. Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability.

Secondary Outcome Measures

1. Change in Brief Pain Intensity Scale at 6 Months [Baseline and 6 months]

   Pain intensity assessed by change in Brief Pain Intensity Scale at 6 months. Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.

2. Change in Generalized Anxiety Disorder at 6 Months [Baseline and 6 months]

   Change in Generalized Anxiety Disorder assessed by 7-item Generalized Anxiety Disorder scale (GAD-7) Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.

3. Change in Depression at 6 Months [Baseline and 6 months]

   Change in Depression at 6 months assessed by 8-item Patient Health Questionnaire (PHQ-8). Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.

4. Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months [6 months]

   Single item measure of patient global impression of change. The investigators will assess this outcome at 6 months. Min=1, max=7, higher scores indicate worse outcome.

5. Mean Change in Average Daily Total Steps at 6 Months [baseline and 6 months]

   Pedometer data recorded over past 7 days on patient logs The investigators will assess mean change in this outcome from baseline to 6 months.

6. 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months [Baseline and 3 months]

   30% improvement on the Roland Morris Disability Questionnaire [RMDQ]) from baseline over the 3-month follow-up period. Minimum = 0 Maximum = 11 Higher scores indicate greater disability The investigators will assess change in this outcome from baseline to 3 months.

7. Change in Brief Pain Intensity Scale at 3 Months [Baseline and 3 months]

   Pain intensity assessed by Brief Pain Intensity Scale Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.

8. Change in Generalized Anxiety Disorder, at 3 Months [Baseline and 3 months]

   Change in Generalized Anxiety Disorder (GAD-7). Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.

9. Change in Depression Using 3 Month [Baseline and 3 months]

   Change in Depression at 3 months using the 8-item Patient Health Questionnaire (PHQ-8) Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.

10. Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months [3 months]

    Single item measure of patient global impression of change. The investigators will assess this outcome using the 3-month assessment. Min=1, max=7, higher scores indicate worse outcome

11. Mean Change in Average Daily Total Steps, at 3 Months [3 months]

    Pedometer data recorded over past 7 days on patient logs. The investigators will assess mean change in this outcome from baseline to 3 months.

Other Outcome Measures

1. Pain Self-efficacy Questionnaire (PSEQ) at 6 Months [6 months]

   Pain self-efficacy questionnaire (PSEQ) at 6 months Min: 10; Max: 60 Higher scores reflect stronger self-efficacy beliefs

2. Exercise Self-efficacy- Exercise Regularity Scale at 6 Months [6 months]

   Exercise self-efficacy and regularity scale at 6 months Min=1, max=10, higher scores indicate better outcome.

3. Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months. [6 months]

   Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 months. Min=0, max=24, higher scores indicate worse outcome.

4. Marcus Social Support Questions [6 months]

   Family Social Support for Exercise at 6 months Min: 0 Max: 40 Higher scores indicate greater social support.

5. Service Utilization Treatment Quality at 6 Months [6 months]

   Rating of quality of pain care received at the VA. Scale 1 (poor) to 5 (excellent)

6. Opioid Use for Pain Treatment at 6 Months [6 months]

   Use of Opioids for pain treatment - Yes/No.

7. Subjective Social Status [3 months]

   Ladder representing subjective social status Min: 1; Max: 10 Higher numbers indicated greater subjective social status

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eligible patients must receive care at the Atlanta VAMC and

• have back, hip or knee pain for a duration of at least 6 months,

• moderate-severe pain intensity and interference with function (defined as a PEG score of 5 or greater),

• self-reported ability to walk at least 1 block, and

• must be able to communicate effectively by telephone (no cognitive disability). The investigators will not exclude patients who are on medication or receiving interventions to treat their chronic pain. The investigators will include the approximately 10% of patients who have no race data; race data will be collected on the brief screening survey.

Exclusion Criteria:

The investigators will not include any vulnerable populations or those who meet any of the following exclusion criteria that may interfere with the outcome assessment: a) moderately severe cognitive impairment defined as > 2 errors on a brief cognitive screener; b) anticipated back, knee, hip, or other major surgery within the next 6 months; c) patients who say they are unable to walk at least a block; d) patients who say they would be unavailable to participate in a 6 month study; e) patients with active psychotic symptoms, suicidality, and/or active manic episode or poorly controlled bipolar disorder, as determined by chart review.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota	United States	55417

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Diana J. Burgess, PhD, Minneapolis VA Health Care System, Minneapolis, MN

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 9, 2020

More Information

Publications

• Bhimani RH, Cross LJ, Taylor BC, Meis LA, Fu SS, Allen KD, Krein SL, Do T, Kerns RD, Burgess DJ. Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans. BMC Musculoskelet Disord. 2017 Jan 13;18(1):15. doi: 10.1186/s12891-016-1363-6.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01983228
• Other Study ID Numbers: IIR 13-030
• First Posted: Nov 13, 2013
• Last Update Posted: Nov 11, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Musculoskeletal Pain; Walking; African American; Telephone Coaching; Pedometer
• Additional relevant MeSH terms: Musculoskeletal Pain

Study Results

Participant Flow

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition will receive pedometers and an informational brochure.	Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
Period Title: Overall Study
STARTED	249	251
COMPLETED	211	189
NOT COMPLETED	38	62

Baseline Characteristics

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group	Total
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.	Total of all reporting groups
Overall Participants	249	251	500
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	166 66.7%	170 67.7%	336 67.2%
>=65 years	83 33.3%	81 32.3%	164 32.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.4 (10.9)	59.6 (11.1)	59.4 (11.0)
Sex: Female, Male (Count of Participants)
Female	66 26.5%	58 23.1%	124 24.8%
Male	183 73.5%	193 76.9%	376 75.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 2%	2 0.8%	7 1.4%
Not Hispanic or Latino	241 96.8%	248 98.8%	489 97.8%
Unknown or Not Reported	3 1.2%	1 0.4%	4 0.8%
Region of Enrollment (Count of Participants)
United States	249 100%	251 100%	500 100%

Outcome Measures

1. Primary Outcome

Title	30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months
Description	30% improvement on the Roland Morris Disability Questionnaire [RMDQ]) from baseline over the 6-month follow-up period. Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability.
Time Frame	Assessed at baseline and 6 months

Outcome Measure Data

Analysis Population Description

Primary Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	154	142
Number [participants w/ >= 30% improvement]	38 15.3%	46 18.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments	measured change as a responder yes/no (30% or greater improvement from baseline).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments	Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.61
	Confidence Interval	(2-Sided) 95%; 0.94 to 2.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Brief Pain Intensity Scale at 6 Months
Description	Pain intensity assessed by change in Brief Pain Intensity Scale at 6 months. Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition will receive pedometers and an informational brochure.	Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
Measure Participants	193	187
Mean (Standard Error) [change in score on a scale]	-0.24 (0.14)	-0.45 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.62 to 0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Generalized Anxiety Disorder at 6 Months
Description	Change in Generalized Anxiety Disorder assessed by 7-item Generalized Anxiety Disorder scale (GAD-7) Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition will receive pedometers and an informational brochure.	Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
Measure Participants	193	187
Mean (Standard Error) [change in score on a scale]	-0.43 (0.41)	-0.95 (0.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -1.69 to 0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in Depression at 6 Months
Description	Change in Depression at 6 months assessed by 8-item Patient Health Questionnaire (PHQ-8). Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition will receive pedometers and an informational brochure.	Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
Measure Participants	193	187
Mean (Standard Error) [change in score on a scale]	-0.96 (0.38)	-1.56 (0.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -1.68 to 0.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months
Description	Single item measure of patient global impression of change. The investigators will assess this outcome at 6 months. Min=1, max=7, higher scores indicate worse outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition will receive pedometers and an informational brochure.	Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
Measure Participants	193	187
Mean (Standard Error) [units on a scale]	3.87 (0.14)	4.26 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95%; -0.00 to 0.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Mean Change in Average Daily Total Steps at 6 Months
Description	Pedometer data recorded over past 7 days on patient logs The investigators will assess mean change in this outcome from baseline to 6 months.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition will receive pedometers and an informational brochure.	Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
Measure Participants	193	187
Mean (Standard Error) [change in number of steps]	397.21 (220.03)	591.11 (243.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
Statistical Test of Hypothesis	p-Value	0.56
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	193.90
	Confidence Interval	(2-Sided) 95%; -454.93 to 842.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months
Description	30% improvement on the Roland Morris Disability Questionnaire [RMDQ]) from baseline over the 3-month follow-up period. Minimum = 0 Maximum = 11 Higher scores indicate greater disability The investigators will assess change in this outcome from baseline to 3 months.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	149	139
Number [participants w/ >= 30% improvement]	34 13.7%	40 15.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments	measured change as a responder yes/no (30% or greater improvement from baseline).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments	Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.49
	Confidence Interval	(2-Sided) 95%; 0.85 to 2.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change in Brief Pain Intensity Scale at 3 Months
Description	Pain intensity assessed by Brief Pain Intensity Scale Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [units on a scale]	0.02 (0.14)	-0.58 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.61
	Confidence Interval	(2-Sided) 95%; -0.99 to -0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change in Generalized Anxiety Disorder, at 3 Months
Description	Change in Generalized Anxiety Disorder (GAD-7). Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [units on a scale]	-0.75 (0.42)	-0.39 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 95%; -0.79 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change in Depression Using 3 Month
Description	Change in Depression at 3 months using the 8-item Patient Health Questionnaire (PHQ-8) Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [units on a scale]	-1.27 (0.42)	-0.79 (0.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; -0.66 to 1.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months
Description	Single item measure of patient global impression of change. The investigators will assess this outcome using the 3-month assessment. Min=1, max=7, higher scores indicate worse outcome
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [units on a scale]	4.51 (0.13)	3.79 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -1.07 to -0.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Mean Change in Average Daily Total Steps, at 3 Months
Description	Pedometer data recorded over past 7 days on patient logs. The investigators will assess mean change in this outcome from baseline to 3 months.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [change in number of steps]	92.97 (207.63)	633.75 (219.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	540.78
	Confidence Interval	(2-Sided) 95%; -28.77 to 1110.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Other Pre-specified Outcome

Title	Pain Self-efficacy Questionnaire (PSEQ) at 6 Months
Description	Pain self-efficacy questionnaire (PSEQ) at 6 months Min: 10; Max: 60 Higher scores reflect stronger self-efficacy beliefs
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [score on a scale]	32.22 (1.08)	35.15 (1.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.93
	Confidence Interval	(2-Sided) 95%; -0.01 to 5.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Other Pre-specified Outcome

Title	Exercise Self-efficacy- Exercise Regularity Scale at 6 Months
Description	Exercise self-efficacy and regularity scale at 6 months Min=1, max=10, higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [score on a scale]	4.45 (0.22)	5.21 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.15 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Other Pre-specified Outcome

Title	Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months.
Description	Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 months. Min=0, max=24, higher scores indicate worse outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [score on a scale]	16.23 (0.53)	15.17 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.07
	Confidence Interval	(2-Sided) 95%; -2.53 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Other Pre-specified Outcome

Title	Marcus Social Support Questions
Description	Family Social Support for Exercise at 6 months Min: 0 Max: 40 Higher scores indicate greater social support.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [score on a scale]	10.37 (0.41)	10.70 (0.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; -0.80 to 1.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Other Pre-specified Outcome

Title	Service Utilization Treatment Quality at 6 Months
Description	Rating of quality of pain care received at the VA. Scale 1 (poor) to 5 (excellent)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [units on a scale]	2.75 (0.11)	2.89 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Other Pre-specified Outcome

Title	Opioid Use for Pain Treatment at 6 Months
Description	Use of Opioids for pain treatment - Yes/No.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only.

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	154	143
Number [participants who reported using Opioids]	79 31.7%	80 31.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments	Logistic regression modeling the odds of yes to using opioids for pain treatment adjusting for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.20
	Confidence Interval	(2-Sided) 95%; 0.66 to 2.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Other Pre-specified Outcome

Title	Subjective Social Status
Description	Ladder representing subjective social status Min: 1; Max: 10 Higher numbers indicated greater subjective social status
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Analysis completed in Black participants only

Arm/Group Title	Arm 1: Usual Care	Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition received a pedometer and an informational brochure about the benefits of walking. They were instructed to use and record their steps with the pedometer the week before the baseline survey and the follow-up surveys.	Intervention participants received a pedometer and tailored materials (a letter and brochure) describing the program and the benefits of walking and physical activity to help manage pain. The manualized, ACTION intervention consisted of six 30- to 60-minute long telephone coaching sessions over an 8-14-week period, delivered by counselors trained in motivational interviewing. Participants were coached to create and write action plans for their proposed walking activity, during the week(s) between coaching sessions, using templates contained in their workbooks. Counselors were also trained to help participants develop specific types of action plans to overcome barriers, strengthen helpful factors, and involve friends and family members. Pedometers were used as a tool to promote walking through feedback, goal setting, and monitoring.
Measure Participants	193	187
Mean (Standard Error) [units on a scale]	5.13 (0.19)	5.47 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care, Arm 2: Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments	Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; -0.18 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data were collected from September 2016 when intervention began through February 2020 when follow-up data collection ended. This is equal to 3 years and 5 months.
Arm/Group Title	Arm 1: Usual Care		Arm 2: Intervention Group
Arm/Group Description	Participants randomized to the usual care control condition will receive pedometers and an informational brochure.		Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Intervention Condition: Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
All Cause Mortality
	Arm 1: Usual Care		Arm 2: Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/249 (0%)		0/250 (0%)
Serious Adverse Events
	Arm 1: Usual Care		Arm 2: Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/249 (0%)		0/250 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1: Usual Care		Arm 2: Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/249 (0%)		0/251 (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.