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Improving Outcomes for Older Veterans With Chronic Back Pain and Depression

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ClinicalTrials.gov Identifier: NCT03896035
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Dallas VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE March 28, 2019
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Recruitment rates [ Time Frame: Through 1 year ]
    Feasibility Outcome
  • Rate of intervention completion [ Time Frame: Through intervention delivery of 8 sessions, up to 24 weeks ]
    Feasibility Outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03896035 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Pain scale [ Time Frame: Through study completion, up to 1 year ]
    Pain intensity on 0-10 scale where higher values are worse pain
  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Through study completion, up to 1 year ]
    Disability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain
  • Depression [ Time Frame: Through study completion, up to 1 year ]
    Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 28, 2019)
Step counts [ Time Frame: Through 8 intervention sessions, up to 24 weeks ]
Physical activity: step counts measured using Omron pedometer. Participants will wear the pedometer clipped to their right lateral waistband for 24 hours per day for 7 consecutive days (except during shower or water activities) to obtain 5 complete days of physical activity data
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Outcomes for Older Veterans With Chronic Back Pain and Depression
Official Title  ICMJE Improving Outcomes for Older Veterans With Chronic Back Pain and Depression (CDA 14-425)
Brief Summary

The overarching goal of this study is to develop and evaluate a telephone delivered behavioral change intervention for older Veterans with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related pain, depressive symptoms, and disability.

Investigators will conduct a pilot randomized controlled trial to assess feasibility for older Veterans with cLBP and depression assigned to receive the behavioral interventions (n=25) versus waitlist control (n=25). For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.

Detailed Description

In this pilot RCT, investigators will assess the feasibility for older Veterans with cLBP and depression assigned to receive the behavioral intervention (n=25) versus the waitlist control (n=25). Follow-up will also include assessments at 6 months and 12 months post-intervention.

Overview of Proposed intervention: The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). Exceptions may be made for highly motivated subjects who had unfortunate life circumstances arise.

For the physical activity component of the intervention, investigators will provide an Omron pedometer to subjects, as previously used in VA research studies. The Omron pedometer will be set up by the research team (stride length, setting date/time) and will be mailed to the subject's home in between session 1 and 2. The health coach will remind the subject that this pedometer will arrive via United States Postal Service mail to their home and to call the research coordinator when it arrives. The research team will provide technical assistance and instructions to the subject regarding use of the Omron pedometer (to be worn on the waist band, daily, all day aside from showers/baths). The research team will also verbally show the subject how to press the mode and memory buttons to obtain weekly step counts for documentation/tracking physical activity. The subjects will be prompted by the health coach or research staff to report out weekly step counts during subsequent coaching sessions.

In addition to the assessments outlined later in this protocol, specifically at 12 months, investigators will conduct in-depth semi-structured interviews with ~10-15 participants (8 from both arms of the pilot trial, the health coaches, 2 primary care providers, and 1 mental health provider) using purposive sampling. The health coach/research coordinator will identify Veterans who are at higher risk for drop-out, were less engaged, or were particularly successful at achieving behavioral change. The purpose of this final interview is to learn about the barriers and facilitators to successful intervention delivery and participant retention from the Veteran, health coach, and provider perspective.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This pilot RCT will use a waitlist control
Masking: Single (Outcomes Assessor)
Masking Description:
The research staff conducting outcomes assessments will be blinded to whether the subject is in active or waitlist group
Primary Purpose: Health Services Research
Condition  ICMJE
  • Chronic Back Pain
  • Depression
  • Aging
Intervention  ICMJE Behavioral: Behavioral Intervention Group
The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).
Study Arms  ICMJE
  • No Intervention: Waitlist Control Group
    The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.
  • Experimental: Behavioral Intervention Group
    For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant.
    Intervention: Behavioral: Behavioral Intervention Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women Veterans aged 65+
  • English-speaking
  • Self-reported low back pain (+/-radiation) on most days for the past 3 months, that interferes with daily activities. Low back pain interferes with daily activities, assessed with the question "does your back pain limit your ability to do activities around the home or activities that you enjoy?"
  • Chronic low back pain with intensity of 4 or higher on 10 point scale
  • Depression, PHQ-9>10 stable (per chart review, no psychotic or suicidal ideation; confirmed over telephone)
  • Capable of participating in home-based activity

Exclusion Criteria:

  • No telephone
  • Not English speaking
  • Unwilling to be randomized to either study arm
  • Self-reported uncorrected hearing or visual disturbance precluding ability to participate in telephone sessions or read pedometer screen
  • Cognitive impairment, assessed by Memory Impairment Screen
  • Lumbar surgery within the last year
  • Self-reported dependence on wheelchair, bed-bound, or severe balance impairment (unable to participate in physical activity intervention)
  • Illness requiring hospitalization within the last 3 months. Specific question: Have you been hospitalized for an illness in the past 3 months that would make participating in a physical activity program challenging or unsafe? (Examples include: fall, gout attacks, stroke, heart attack, heart failure, or surgery for blocked arteries)
  • Suicidal ideation, prior psychotic episodes requiring hospitalization within the last year
  • Already achieving physical activity goals of > 4 hours per week. Recommendation are for >150 minutes/ week of moderate activity. Four hours is 240 minutes and exceeds this threshold.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cassie Lusk (214) 857-2602 cassie.lusk@va.gov
Contact: Una E Makris, MD MSc Una.Makris2@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896035
Other Study ID Numbers  ICMJE CDX 19-001
K2HX001916 ( Other Identifier: VA HSRD )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Dallas VA Medical Center
Investigators  ICMJE
Principal Investigator: Una E. Makris, MD MSc VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
PRS Account VA Office of Research and Development
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP