Clinical trial NCT01983228: A Proactive Walking Trial to Reduce Pain in Black Veterans
Official title: A Proactive Walking Trial to Reduce Pain in Black Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Musculoskeletal Pain
Walking
African American
Telephone Coaching
Pedometer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-11-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months
timeFrame: Assessed at baseline and 6 months
Secondary outcomes:
measure: Change in Brief Pain Intensity Scale at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Generalized Anxiety Disorder at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Depression at 6 Months
timeFrame: Baseline and 6 months
measure: Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months
timeFrame: 6 months
measure: Mean Change in Average Daily Total Steps at 6 Months
timeFrame: baseline and 6 months
measure: 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Brief Pain Intensity Scale at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Generalized Anxiety Disorder, at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Depression Using 3 Month
timeFrame: Baseline and 3 months
measure: Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months
timeFrame: 3 months
measure: Mean Change in Average Daily Total Steps, at 3 Months
timeFrame: 3 months
Other outcomes:
measure: Pain Self-efficacy Questionnaire (PSEQ) at 6 Months
timeFrame: 6 months
measure: Exercise Self-efficacy- Exercise Regularity Scale at 6 Months
timeFrame: 6 months
measure: Pain-related Fear Avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) Scale 1 at 6 Months.
timeFrame: 6 months
measure: Marcus Social Support Questions
timeFrame: 6 months
measure: Service Utilization Treatment Quality at 6 Months
timeFrame: 6 months
measure: Opioid Use for Pain Treatment at 6 Months
timeFrame: 6 months
measure: Subjective Social Status
timeFrame: 3 months
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Diana J. Burgess, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 Intervention for Black Patients with Chronic Musculoskeletal Pain. J Gen Intern Med. 2022 Nov;37(14):3585-3593. doi: 10.1007/s11606-021-07376-2. Epub 2022 Feb 7.
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 With Chronic Pain. J Pain. 2023 Jan;24(1):55-67. doi: 10.1016/j.jpain.2022.07.002. Epub 2022 Sep 23.