Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy

Study Overview
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Brief Summary
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The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo's EOA system with integrated mobile CBT but without tapering to improve The Pain Catastrophizing Scale (PCS) scores, and secondarily scores on the VNS pain scale, the Tampa Scale of Kinesiophobia (TSK), and patient satisfaction scores in the subacute period (defined as 2 weeks to 3 months post TKR). Statistically significant positive results on the Pain Catastrophizing Scale (PCS) will trigger phase 2. Phase 1 will also inform the detailed conditions and patient management algorithms for Phase II.

Detailed Description
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The InCaveo End Opioid Addiction (EOA) System is an integrated pain management therapeutic and opioid tapering system providing alternate treatment options via self-service Cognitive Behavior Therapy (CBT) built into a mobile software app, patient medication usage, and tracking of patient PROs. It is designed to be used alongside Usual Standard of Care using Pill Bottles or to simplify, Usual Care with Pill Bottles (UCPB) treatment practices. The InCaveo EOA System is designed to improve a set of patient outcome measures, primarily Pain Catastrophizing Scale (PCS) and secondarily the Visual Numeric Pain (VNS), Kinesiophobia (TSK) and satisfaction scores while facilitating the ability of patients to taper off their pain medication faster than through the use of USPB in the management of post-operative pain. In order to reduce confounding variables, the study will focus on pain management following a single surgical procedure: Total Knee Replacement (TKR) surgery.

Official Title
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Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy to Lower Pain Catastrophizing Scores

Conditions
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Pain, Postoperative, Analgesics, Opioid

Intervention / Treatment
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* Device: InCaveo's EOA system with integrated mobile CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a Pain Catastrophizing Score >16 55 years of age and older. English speaking. Has a smartphone (iPhone). Able to swallow oral medications. No continuous daily opioid as defined as more than 15 days in the 30 days before surgery. Undergoing TKR surgery. Patients who are willing and able to comply with scheduled visits and study procedures. Exclusion Criteria: Diagnosed with Opioid Use Disorder (OUD). Actively using illicit drugs. Allergy to opioids Older than 85 years

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel-group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InCaveo EOA System<br>InCaveo EOA System (including integrated CBT but without tapering) group | Device: InCaveo's EOA system with integrated mobile CBT<br>* integrated pain management therapeutic and tapering system including a software apt that manages and tracks patient-reported outcomes, including pain levels, medication use, quality of life<br>|
| No Intervention: Control Group-usual care with pill bottles<br>UCPB group-usual care with pill bottles | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing Scale (PCS) | A measure of the extent of catastrophizing | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain