A Proactive Walking Trial to Reduce Pain in Black Veterans

Musculoskeletal Pain Clinical Trial

— ACTION  

Official title:

A Proactive Walking Trial to Reduce Pain in Black Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983228
• Other study ID #: IIR 13-030
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: February 27, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Burgess DJ, Hagel Campbell E, Hammett P, Allen KD, Fu SS, Heapy A, Kerns RD, Krein SL, Meis LA, Bangerter A, Cross LJS, Do T, Saenger M, Taylor BC. Taking ACTION to Reduce Pain: a Randomized Clinical Trial of a Walking-Focused, Proactive Coaching Interven — View Citation

Hammett PJ, Eliacin J, Makris UE, Allen KD, Kerns RD, Heapy A, Goldsmith ES, Meis LA, Taylor BC, Saenger M, Cross LJS, Do T, Branson M, Burgess DJ. An Analysis of the Role of Mental Health in a Randomized Trial of a Walking Intervention for Black Veterans — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Self-efficacy Questionnaire (PSEQ) at 6 Months	Pain self-efficacy questionnaire (PSEQ) at 6 months Min: 10; Max: 60 Higher scores reflect stronger self-efficacy beliefs	6 months
Other	Exercise Self-efficacy- Exercise Regularity Scale at 6 Months	Exercise self-efficacy and regularity scale at 6 months Min=1, max=10, higher scores indicate better outcome.	6 months
Other	Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 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.	6 months
Other	Marcus Social Support Questions	Family Social Support for Exercise at 6 months Min: 0 Max: 40 Higher scores indicate greater social support.	6 months
Other	Service Utilization Treatment Quality at 6 Months	Rating of quality of pain care received at the VA. Scale 1 (poor) to 5 (excellent)	6 months
Other	Opioid Use for Pain Treatment at 6 Months	Use of Opioids for pain treatment - Yes/No.	6 months
Other	Subjective Social Status	Ladder representing subjective social status Min: 1; Max: 10 Higher numbers indicated greater subjective social status	3 months
Primary	30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 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.	Assessed at baseline and 6 months
Secondary	Change in Brief Pain Intensity Scale at 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.	Baseline and 6 months
Secondary	Change in Generalized Anxiety Disorder at 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.	Baseline and 6 months
Secondary	Change in Depression at 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.	Baseline and 6 months
Secondary	Overall Improvement Assessed by Patient Global Impression of Change Scale at 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.	6 months
Secondary	Mean Change in Average Daily Total Steps at 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.	baseline and 6 months
Secondary	30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 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.	Baseline and 3 months
Secondary	Change in Brief Pain Intensity Scale at 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.	Baseline and 3 months
Secondary	Change in Generalized Anxiety Disorder, at 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.	Baseline and 3 months
Secondary	Change in Depression Using 3 Month	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.	Baseline and 3 months
Secondary	Overall Improvement Assessed by Patient Global Impression of Change Scale at 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	3 months
Secondary	Mean Change in Average Daily Total Steps, at 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.	3 months