Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836169
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-04-05
Brief Title:
Phase 1 Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy
Sponsor:
InCaveo
Organization:
InCaveo
Study Overview
Official Title:
Phase 1 Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy to Lower Pain Catastrophizing Scores
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P1RESPECT
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 InCaveos 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None