Trial Outcomes & Findings for A Proactive Walking Trial to Reduce Pain in Black Veterans (NCT NCT01983228)

NCT ID: NCT01983228

Last Updated: 2023-07-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 500 participants
• Primary outcome timeframe: Assessed at baseline and 6 months
• Results posted on: 2023-07-27

Participant Flow

Participant milestones

Measure	Arm 1: Usual Care Participants randomized to the usual care control condition will receive pedometers and an informational brochure.	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. 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.
Overall Study STARTED	249	251
Overall Study COMPLETED	211	189
Overall Study NOT COMPLETED	38	62

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Proactive Walking Trial to Reduce Pain in Black Veterans

Baseline characteristics by cohort

Measure	Arm 1: Usual Care n=249 Participants 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.	Arm 2: Intervention Group n=251 Participants 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 n=500 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	166 Participants n=5 Participants	170 Participants n=7 Participants	336 Participants n=5 Participants
Age, Categorical >=65 years	83 Participants n=5 Participants	81 Participants n=7 Participants	164 Participants n=5 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 10.9 • n=5 Participants	59.6 years STANDARD_DEVIATION 11.1 • n=7 Participants	59.4 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	58 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	183 Participants n=5 Participants	193 Participants n=7 Participants	376 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	241 Participants n=5 Participants	248 Participants n=7 Participants	489 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	249 Participants n=5 Participants	251 Participants n=7 Participants	500 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at baseline and 6 months

Population: Primary Analysis completed in Black participants only.

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.

Outcome measures

Measure	Arm 1: Usual Care n=154 Participants 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.	Arm 2: Intervention Group n=142 Participants 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.
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months	38 participants w/ >= 30% improvement	46 participants w/ >= 30% improvement

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Analysis completed in Black participants only

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.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Change in Brief Pain Intensity Scale at 6 Months	-0.24 change in score on a scale Standard Error 0.14	-0.45 change in score on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Analysis completed in Black participants only.

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.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Change in Generalized Anxiety Disorder at 6 Months	-0.43 change in score on a scale Standard Error 0.41	-0.95 change in score on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Analysis completed in Black participants only.

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.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Change in Depression at 6 Months	-0.96 change in score on a scale Standard Error 0.38	-1.56 change in score on a scale Standard Error 0.40

SECONDARY outcome

Timeframe: 6 months

Population: Analysis completed in Black participants only.

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.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months	3.87 units on a scale Standard Error 0.14	4.26 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Analysis completed in Black participants only.

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Mean Change in Average Daily Total Steps at 6 Months	397.21 change in number of steps Standard Error 220.03	591.11 change in number of steps Standard Error 243.02

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Analysis completed in Black participants only.

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.

Outcome measures

Measure	Arm 1: Usual Care n=149 Participants 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.	Arm 2: Intervention Group n=139 Participants 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.
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months	34 participants w/ >= 30% improvement	40 participants w/ >= 30% improvement

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Analysis completed in Black participants only

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.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Change in Brief Pain Intensity Scale at 3 Months	0.02 units on a scale Standard Error 0.14	-0.58 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Analysis completed in Black participants only.

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.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Change in Generalized Anxiety Disorder, at 3 Months	-0.75 units on a scale Standard Error 0.42	-0.39 units on a scale Standard Error 0.44

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Analysis completed in Black participants only.

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.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Change in Depression Using 3 Month	-1.27 units on a scale Standard Error 0.42	-0.79 units on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: 3 months

Population: Analysis completed in Black participants only.

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months	4.51 units on a scale Standard Error 0.13	3.79 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: 3 months

Population: Analysis completed in Black participants only.

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Mean Change in Average Daily Total Steps, at 3 Months	92.97 change in number of steps Standard Error 207.63	633.75 change in number of steps Standard Error 219.56

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Analysis completed in Black participants only.

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Pain Self-efficacy Questionnaire (PSEQ) at 6 Months	32.22 score on a scale Standard Error 1.08	35.15 score on a scale Standard Error 1.09

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Analysis completed in Black participants only.

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Exercise Self-efficacy- Exercise Regularity Scale at 6 Months	4.45 score on a scale Standard Error 0.22	5.21 score on a scale Standard Error 0.23

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Analysis completed in Black participants only.

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

Min=0, max=24, higher scores indicate worse outcome.

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months.	16.23 score on a scale Standard Error 0.53	15.17 score on a scale Standard Error 0.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Analysis completed in Black participants only.

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Marcus Social Support Questions	10.37 score on a scale Standard Error 0.41	10.70 score on a scale Standard Error 0.43

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Analysis completed in Black participants only.

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Service Utilization Treatment Quality at 6 Months	2.75 units on a scale Standard Error 0.11	2.89 units on a scale Standard Error 0.12

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Analysis completed in Black participants only.

Use of Opioids for pain treatment - Yes/No.

Outcome measures

Measure	Arm 1: Usual Care n=154 Participants 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.	Arm 2: Intervention Group n=143 Participants 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.
Opioid Use for Pain Treatment at 6 Months	79 participants who reported using Opioids	80 participants who reported using Opioids

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: Analysis completed in Black participants only

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

Outcome measures

Measure	Arm 1: Usual Care n=193 Participants 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.	Arm 2: Intervention Group n=187 Participants 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.
Subjective Social Status	5.13 units on a scale Standard Error 0.19	5.47 units on a scale Standard Error 0.19

Adverse Events

Arm 1: Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Intervention Group

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. Diana Burgess, Principal Investigator

Minneapolis Veterans Affairs Health Care System

Phone: 612-467-1591

Email: diana.burgess@va.gov

Results disclosure agreements

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