Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400602
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-01
Brief Title:
Health Coaching for Back Pain After Emergency Department Discharge
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Integrative Health Coaching for Back Pain An Emergency Department-to-Home Recovery Model
Status:
RECRUITING
Status Verified Date:
2024-05
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 goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department ED
The main questions this feasibility trial aims to answer are
Is our health coaching intervention and randomized trial methodology feasible to conduct
Is our health coaching intervention acceptable to participants and ED providers
Participants will be randomized to one of two groups usual ED care plus health coaching or usual ED care plus education and complete outcome assessments at 3 and 6 months after ED discharge Participants and ED providers will also complete an interview
The main questions this feasibility trial aims to answer are
Is our health coaching intervention and randomized trial methodology feasible to conduct
Is our health coaching intervention acceptable to participants and ED providers
Participants will be randomized to one of two groups usual ED care plus health coaching or usual ED care plus education and complete outcome assessments at 3 and 6 months after ED discharge Participants and ED providers will also complete an interview
Detailed Description:
This study is a two-group randomized feasibility trial of usual ED care plus either remote health coaching or remote education in patients with acute exacerbation of chronic low back pain presenting to the ED We hypothesize that our health coaching intervention and randomized trial methodology will be feasible and that our health coaching intervention will be acceptable to participants and ED providers
Forty participants will be randomized 20 per group with 36 90 retained in the trial up to 6 months follow-up Eligible patients presenting to the ED with a chief complaint of acute exacerbation of chronic low back pain will be randomized Patients will be enrolled during or shortly after their ED visit asked to complete a baseline questionnaire and then randomized Randomized participants will receive 8 calls from either a health coach or education provider and be asked to complete assessments at 3 and 6 months after ED discharge Interviews will be conducted with randomized participants and 15 ED providers asking about their experience with the intervention
Forty participants will be randomized 20 per group with 36 90 retained in the trial up to 6 months follow-up Eligible patients presenting to the ED with a chief complaint of acute exacerbation of chronic low back pain will be randomized Patients will be enrolled during or shortly after their ED visit asked to complete a baseline questionnaire and then randomized Randomized participants will receive 8 calls from either a health coach or education provider and be asked to complete assessments at 3 and 6 months after ED discharge Interviews will be conducted with randomized participants and 15 ED providers asking about their experience with the intervention
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?:
None
Is an FDA AA801 Violation?:
None