Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03896035 |
| Other study ID # |
CDX 19-001 |
| Secondary ID |
K2HX001916 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 28, 2019 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
