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NCT03353272 · ClinicalTrials.gov registry record · NA
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT03353272 is a NA study that has completed, run by Duke University. The registered enrollment target is 55 participants.
The verdict
NCT03353272, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and beliefs regarding the need for specific treatment methods and the timing and intensity of these methods. Brief interventions designed to alter and enhance treatment expectations for conservative care and have been shown to improve patient expectations, but to date, no studies have explored whether such interventions can influence patient decisions to pursue surgical care. The investigators propose a comprehensive intervention that involves Patient Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change expectations, will reduce the likelihood that patients will choose to have shoulder surgery and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form the core of our PEERC protocol are patient-centered and are designed to empower the patient in their own recovery process. Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes, and follow up expectations (secondary).
Interventions
- BEHAVIORAL Patient Engagement Education and Restructuring of Cognitions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2022-10-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03353272
The ClinicalTrials.gov registry entry for NCT03353272 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Patient Engagement Education and Restructuring of Cognitions is the first listed.
NCT03353272 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03353272 about?
NCT03353272 is a clinical study titled "The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain". Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expecta...
What is the current status of trial NCT03353272?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2018-09-18. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT03353272?
The interventions under investigation include: Patient Engagement Education and Restructuring of Cognitions (BEHAVIORAL).
Who is sponsoring clinical trial NCT03353272?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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