Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy
P1RESPECT
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedApril 8, 2021
April 1, 2021
6 months
April 5, 2021
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Catastrophizing Scale (PCS)
A measure of the extent of catastrophizing
60 days
Study Arms (2)
InCaveo EOA System
EXPERIMENTALInCaveo EOA System (including integrated CBT but without tapering) group
Control Group-usual care with pill bottles
NO INTERVENTIONUCPB group-usual care with pill bottles
Interventions
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
Eligibility Criteria
You may qualify if:
- Patient has a Pain Catastrophizing Score \>16
- 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.
You may not qualify if:
- Diagnosed with Opioid Use Disorder (OUD).
- Actively using illicit drugs.
- Allergy to opioids
- Older than 85 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InCaveolead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hoyman Hong, MD
InCaveo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2021
First Posted
April 8, 2021
Study Start
October 1, 2021
Primary Completion
April 1, 2022
Study Completion
May 1, 2022
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share