Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03705104
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2018-09-20
Brief Title:
Living Well With Chronic Pain
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Living Well With Chronic Pain Using Person-centered E-health Design to Support Self-management
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
EPIO
Brief Summary:
The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain
Detailed Description:
Chronic pain conditions are common and difficult to cure As much as 30 of adults in Norway experience moderate-to-severe chronic pain ie pain having lasted more than 3 months Chronic pain is also the most common cause of sick leave and disability pension in Norway Despite a clear request from the authorities e-health interventions for chronic pain has not yet been tested and implemented
The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain using outcome measures such as pain intensity pain acceptance anxietydepression and quality of life
The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material The 9 modules will be distributed over minimum 27 days minimum 3 days per module The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group Both groups will receive outcome measures to complete at baseline and at 3 6 and 12 months
Post-RCT the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only
The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain using outcome measures such as pain intensity pain acceptance anxietydepression and quality of life
The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material The 9 modules will be distributed over minimum 27 days minimum 3 days per module The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group Both groups will receive outcome measures to complete at baseline and at 3 6 and 12 months
Post-RCT the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only
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