NCT04836169|UnknownFDA Device
Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy
P1RESPECT
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P1RESPECT
Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 5, 2021
Actual (reported)April 8, 2021
Actual (reported)October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pain Catastrophizing Scale (PCS)
A measure of the extent of catastrophizing
60 days
InCaveo EOA System (including integrated CBT but without tapering) group
UCPB group-usual care with pill bottles
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hoyman Hong, MD
InCaveo
First Submitted
April 5, 2021
First Posted
April 8, 2021
Study Start
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
April 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 8, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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