Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy (P1RESPECT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Analgesics, Opioid
• Intervention / Treatment: Device: InCaveo's EOA system with integrated mobile CBT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Harris, BS; Phone Number: 8326776747; Email: cindy@clinregconsult.com
• Study Contact Backup: Name: Michael A Daniel, MBA; Phone Number: 4154070223; Email: madaniel@clinregconsult.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient has a Pain Catastrophizing Score >16
2. 55 years of age and older.
3. English speaking.
4. Has a smartphone (iPhone).
5. Able to swallow oral medications.
6. No continuous daily opioid as defined as more than 15 days in the 30 days before surgery.
7. Undergoing TKR surgery.
8. Patients who are willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria:

1. Diagnosed with Opioid Use Disorder (OUD).
2. Actively using illicit drugs.
3. Allergy to opioids
4. Older than 85 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InCaveo EOA System; InCaveo EOA System (including integrated CBT but without tapering) group	Device: InCaveo's EOA system with integrated mobile CBT; 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
No Intervention: Control Group-usual care with pill bottles; UCPB group-usual care with pill bottles

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InCaveo
• Investigators: Principal Investigator: Hoyman Hong, MD, InCaveo

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: InCaveoDanielandDaniel2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No