A Proactive Walking Trial to Reduce Pain in Black Veterans

NCT01983228 | Completed Results

• 1 other identifier: IIR 13-030
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

Musculoskeletal Pain; Walking; African American; Telephone Coaching; Pedometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Brief Pain Intensity Scale at 6 Months

  Baseline and 6 months

• Change in Generalized Anxiety Disorder at 6 Months

  Baseline and 6 months

• Change in Depression at 6 Months

  Baseline and 6 months

• Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months

  6 months

• Mean Change in Average Daily Total Steps at 6 Months

  baseline and 6 months

Other Outcomes (7)

• Pain Self-efficacy Questionnaire (PSEQ) at 6 Months

  6 months

• Exercise Self-efficacy- Exercise Regularity Scale at 6 Months

  6 months

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

  6 months

Study Arms (2)

Arm 1: Usual Care

NO INTERVENTION

Participants randomized to the usual care control condition will receive pedometers and an informational brochure.

Arm 2: Intervention Group

EXPERIMENTAL

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

Interventions

Intervention Condition BEHAVIORAL

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.

Arm 2: Intervention Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Related Publications (4)

• 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.

  PMID: 28086853 BACKGROUND

• 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.

  PMID: 35132545 RESULT

• 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.

  PMID: 36162790 RESULT

• Hammett PJ, Eliacin J, Saenger M, Allen KD, Meis LA, Krein SL, Taylor BC, Branson M, Fu SS, Burgess DJ. The Association Between Racialized Discrimination in Health Care and Pain Among Black Patients With Mental Health Diagnoses. J Pain. 2024 Jan;25(1):217-227. doi: 10.1016/j.jpain.2023.08.004. Epub 2023 Aug 15.

  PMID: 37591480 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Diana Burgess, Principal Investigator
• Organization: Minneapolis Veterans Affairs Health Care System

diana.burgess@va.gov

612-467-1591

Study Officials

• Diana J. Burgess, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: July 1, 2016
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: July 27, 2023
• Results First Posted: June 9, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)