Viewing Study NCT06407115



Ignite Creation Date: 2024-05-11 @ 8:31 AM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06407115
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-06-03
First Post: 2024-05-06

Brief Title: Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain
Sponsor: University of Washington
Organization: University of Washington

Study Overview

Official Title: Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-08
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: AIM-CP
Brief Summary: Chronic pain affects over 20 US adults and has debilitating effects on quality of life and physical and mental health Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain The 46 million Americans who live in rural areas frequently lack access to evidence-based non-pharmacologic treatments for chronic pain As such a critical need exists to implement effective comprehensive programs for pain management that include treatment options other than medications Nurse care management NCM has been successfully used to enhance care for individuals with other long-term health issues The study teams proposes to adapt pilot and implement a NCM model that includes care coordination cognitive behavioral therapy CBT and referrals to a remotely delivered exercise program for rural patients with chronic pain
Detailed Description: Care managers will provide care coordination to help patients address their health holistically and help link them key resources in the community In addition the care managers will be trained to deliver cognitive behavioral therapy CBT to address unhelpful thought patterns and behaviors around chronic pain and also facilitate patients participation in EnhanceFitness tele-EF an evidence-based exercise program that can be accessed from home The rationale is that both tele-EF and CBT have been independently shown to improve pain functioning and quality of life and that care managers could support patients in accessing and engaging in these services

This phase allows the study team to prepare for a randomized controlled trial to test the adapted NCM model with rural patients who have chronic pain Investigators plan to test the intervention in rural serving health care systems using two practice-based research networks with substantial rural presence the WWAMI Washington Wyoming Alaska Montana and Idaho region Practice and Research Network and Mecklenburg Area Partnership for Primary Care Research in North Carolina In combination recruitment in these two networks will allow the study team to reach ethnically diverse participants across broad rural geographies

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
Secondary IDs
Secondary ID Type Domain Link
1UG3NR020930 NIH None httpsreporternihgovquickSearch1UG3NR020930