Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UG3 Pilot

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: RAMP program

• Registration Number: NCT06568250
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

Brief Summary

This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3) the investigators will conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-07
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Veteran participants must be rural dwelling
• Patient's Veterans Affairs (VA) primary care provider is in the Southeast region of the US
• Email address in the VA electronic health record (EHR)
• Report pain at least most days in the past 3 months
• Brief Pain Inventory (BPI) Pain Interference subscale score of 4 or greater
• Willingness and ability to complete study activities including meeting remotely via videoconferencing when program sessions are held

Exclusion Criteria

• Participation in a prior project conducted by the study team on mindfulness for pain (NCT0456158) or an engagement activities advisor for the current project
• Current enrollment in a research study for pain
• Current enrollment in a similar facilitated, multi-week, multi-modal CIH program
• Severe, poorly controlled psychiatric or substance use disorder (based on chart review using structured checklists, conducted by trained staff who are trained and supervised by a clinical psychologist)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	RAMP program	-

Primary Outcome Measures

Name	Time	Method
Percentage of Female and Racial/Ethnic Minoritized Participants Recruited	3 months	At least 35% female and 35% racial/ethnic minority patients recruited
Intervention Fidelity Based on Observation By Trained Raters	3 months	Facilitators deliver 90% of session activities 90% of the time
Percentage of Participants Who Complete Post-Treatment Data Collection	3 month	\>80% complete post-treatment data collection (at 3 months)
Number of Participants Recruited	3 months	40 rural-dwelling VA patients recruited
Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale	3 months	75% satisfied with RAMP program
Percentage of Participants Who Attend/Engage with Recommended Number of Sessions	3 months	75% attend/engage with recommended # of sessions (≥ 7/12)

Trial Locations

Locations (1)

Minneapolis VAMC; 🇺🇸 Minneapolis, Minnesota, United States