Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01638871
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2012-06-21
Brief Title:
Internet-Based Osteoarthritis Pain Coping Skills Intervention
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Internet-Based Osteoarthritis Pain Coping Skills Intervention
Status:
COMPLETED
Status Verified Date:
2014-02
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:
PainCOACH
Brief Summary:
The purpose of this study is to translate a proven pain coping skills intervention for osteoarthritis OA patients into an engaging and easy-to-use Internet-based intervention that uses innovative technologies to mimic traditional in-person training sessions
Detailed Description:
Twenty-one million Americans live with osteoarthritis OA a progressive joint disease that causes stiffness pain reduced range of motion distress and decrements in physical social and role functioning Medical treatments for OA pain are limited and present risks especially for older populations However cognitive behavioral pain coping skills interventions have proven effective for decreasing OA pain disability and distress Unfortunately existing programs reach a limited number of patients because they require patients to travel to receive in-person training There is a need for interventions that address the needs of a larger proportion of the rapidly growing population of people whose functioning and quality of life are severely diminished by OA Delivering proven pain management interventions via the Internet is a promising way to address this need especially in light of increasing use of the Internet by older Americans To be most effective an Internet-based intervention would need to mimic key features of in-person interventions The proposed intervention will do that by translating a proven in-person pain coping skills protocol into an interactive Internet-based application that uses multimedia and expert systems technology to mimic in-person interventions It will provide individualized feedback interactive problem solving and animated demonstrations and it will incorporate learning techniques from Banduras Social Cognitive Theory including modeling mastery experiences and social reinforcement The project includes two phases corresponding to two specific aims In Phase I the investigators will translate the in-person intervention for delivery on the Internet This phase will including gathering feedback from patient and expert therapist focus groups which will help refine the program In Phase II the investigators will conduct a small-scale randomized controlled trial that will enable us to examine and refine features designed to increase motivation and adherence over the course of the 8-week Internet-based intervention The trial will also enable the investigators to demonstrate its feasibility tolerability safety and promise The investigators hypothesize that the trial will demonstrate the effectiveness of the Internet for delivery of this OA pain coping skills intervention Taken together these activities will prepare the program for testing in a full-scale randomized controlled trial in the next stage of this research The promise of this project is enhanced by the multi-disciplinary research team which has expertise in the conduct of cognitive behavioral interventions that teach OA patients to use coping skills to manage their pain developing and implementing individualized computerized feedback reports using expert systems technology and development of engaging user-friendly interactive computer-based programs for learning and assessment Relevance This Internet-based OA pain coping skills intervention targets a significant individual and public health problem and expands access to an empirically-supported pain self-management program so that it can reach a greater proportion of the large and growing population of people suffering from OA pain and related disability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AR057346-02 | NIH | None | httpsreporternihgovquickSearch5R01AR057346-02 |