Collecting Outcomes and Managing Pain After Surgery
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT03834818
- Status
- Recruiting
Conditions
- Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- COMPAS Participants — BEHAVIORALThe schedule of events for this study are as follows: Day 1 Pre-Surgery: * Download the Medable App * Register to the study * Validated Questionnaires * Active Task Every Day * 9:00 a.m. Daily Questions * 9:00 p.m. Daily Questions Outcome Surveys and Active Task: * Day 1 Pre-Surgery * 1-Week Post Operation * 2-Weeks Post Operation * 1-Month Post Operation * 3-Months Post Operation * 6-Months Post Operation
Study Details
The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.
Key Dates
- Start date
- Jan 13, 2025
- Status verified
- May 2026
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 10,000 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: COMPAS ParticipantsPatents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.
Primary Outcome Measure
Reported Pain of Participants measured via PROMIS-29 [ Time Frame: 6 Months ]
Central Contacts
- Ashley Burke+1 919 681 2849
- Michael Bullock, MD+1 919 668 2024
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke Orthopaedics | Durham | North Carolina | 27710 |
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