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Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE) for Pain (COOPERATE Trial)
N/A
Waitlist Available
Led By Marianne Sassi Matthias, PhD MS BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
COOPERATE Trial Summary
This trial is testing an intervention to improve minority Veterans' active participation in their pain care by focusing on 2 essential skill sets: 1) goal-setting and prioritization, and 2) communication skills.
COOPERATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Activation
Secondary outcome measures
Anxiety
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
Depression (PHQ8)
+2 moreOther outcome measures
Covariate--Working alliance
Covariate--length of patient-provider relationship
Covariate--patient-provider gender and race concordance
COOPERATE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: COOPERATE Intervention ArmExperimental Treatment1 Intervention
Intervention patients will focus on 1) goal clarification/prioritization; 2) communication skills. There are 6 total sessions delivered individually over 12 weeks: 4 sessions teaching skills (30 min each) and 2 booster sessions delivered once/month for the next 2 months. Intervention will be delivered by telephone.
Group II: Attention Control ArmActive Control1 Intervention
Veterans randomized to the control group will receive phone calls on the same schedule as intervention Veterans. During these phone calls, study staff will ask Veterans a series of questions about their pain, self-management activities, and any changes they have experienced since the last call. These phone calls are designed to control for attention only, and Veterans will not be offered specific information or advice about their pain or its management (with the exception of suggesting a doctor visit if warranted).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)
2018
N/A
~250
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,179 Total Patients Enrolled
20 Trials studying Pain
4,774 Patients Enrolled for Pain
Marianne Sassi Matthias, PhD MS BAPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN
3 Previous Clinical Trials
531 Total Patients Enrolled
2 Trials studying Pain
511 Patients Enrolled for Pain
Frequently Asked Questions
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