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

NCT ID: NCT04836169

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2022-05-31

Brief Summary

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

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.

Conditions

Pain, Postoperative; Analgesics, Opioid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

InCaveo EOA System

InCaveo EOA System (including integrated CBT but without tapering) group

Group Type: EXPERIMENTAL

InCaveo's EOA system with integrated mobile CBT

Intervention Type: DEVICE

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

Control Group-usual care with pill bottles

UCPB group-usual care with pill bottles

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InCaveo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoyman Hong, MD

Role: PRINCIPAL_INVESTIGATOR

InCaveo

Central Contacts

Cynthia Harris, BS

Role: CONTACT

cindy@clinregconsult.com

8326776747

Michael A Daniel, MBA

Role: CONTACT

madaniel@clinregconsult.com

4154070223

Other Identifiers

InCaveoDanielandDaniel2021

Identifier Type: -

Identifier Source: org_study_id