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NCT06091202 Clinical Trial

Tele-Collaborative Outreach to Rural Patients With Chronic Pain

Chronic Pain Clinical Trial

— CORPs  

Official title:
Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06091202
Other study ID # 25384
Secondary ID 1UG3AT012257-01
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 2, 2023
Est. completion date September 2027

Study information
Verified date September 2023
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall goal of this multisite pilot trial is to pilot test and refine recruitment, intervention, and data collection protocols at four VA study sites, in preparation for a larger-scale clinical trial.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 24
Est. completion date September 2027
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - U.S. Veteran - Access to landline or cell phone - Internet Access - Rural Residence based on Rural Urban Commuting Area codes - High Impact Chronic pain, determined through a phone screening - English Speaking Exclusion Criteria: - Cognitive impairment that would impact participation in the study - Plans to move in the next 3 months - Surgery in the past 3 months - In long-term inpatient or hospice care - Inability, or unwillingness, to complete informed consent via DocuSign - Active participation in another pain intervention study

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• CORPs Intervention
Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 1 month. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 1-month follow-up, and a qualitative interview at 1-month follow-up to help inform the larger clinical trial.
• Minimally Enhanced Usual Care (MEUC)
Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 1 month. The primary outcome is a change in pain interference.

Locations
Country Name City State
United States VA North Texas Health Care System Dallas Texas
United States VA Minneapolis Health Care System Minneapolis Minnesota
United States VA Tennessee Valley Health Care System Nashville Tennessee
United States VA Portland Health Care System Portland Oregon

Sponsors (6)
Lead Sponsor Collaborator
Oregon Health and Science University Minneapolis Veterans Affairs Medical Center, National Center for Complementary and Integrative Health (NCCIH), North Texas Veterans Healthcare System, Portland VA Medical Center, VA Tennessee Valley Health Care System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Interference The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure. 1 Month
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