Ignite Creation Date:
2024-05-06 @ 12:58 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03896035
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2019-02-05
Brief Title:
Improving Outcomes for Older Veterans With Chronic Back Pain and Depression
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Outcomes for Older Veterans With Chronic Back Pain and Depression CDA 14-425
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n25 versus waitlist control n25 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
Investigators will conduct a pilot randomized controlled trial to assess feasibility for older Veterans with cLBP and depression assigned to receive the behavioral interventions n25 versus waitlist control n25 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 n25 versus the waitlist control n25 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 datetime and will be mailed to the subjects 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 showersbaths The research team will also verbally show the subject how to press the mode and memory buttons to obtain weekly step counts for documentationtracking 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 coachresearch 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
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 datetime and will be mailed to the subjects 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 showersbaths The research team will also verbally show the subject how to press the mode and memory buttons to obtain weekly step counts for documentationtracking 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 coachresearch 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K2HX001916 | OTHER | VA HSRD | None |