Pain, PostoperativeP1RESPECTNCT04836169
Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy
A study testing InCaveo's EOA system with integrated mobile CBT in people with Pain, Postoperative and Analgesics, Opioid, run by InCaveo.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Pain, Postoperative, Analgesics, Opioid
- What is being tested?
- InCaveo's EOA system with integrated mobile CBT
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a Pain Catastrophizing Score >16
- 55 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.
Who cannot join
- Diagnosed with Opioid Use Disorder (OUD).
- Actively using illicit drugs.
- Allergy to opioids
- Older than 85 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- InCaveo's EOA system with integrated mobile CBT
- Keywords
- pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InCaveo's EOA system with integrated mobile CBTDevice
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
| Study group | Role | What they receive |
|---|---|---|
| InCaveo EOA System | Experimental | InCaveo EOA System (including integrated CBT but without tapering) group Receives: Device: InCaveo's EOA system with integrated mobile CBT |
| Control Group-usual care with pill bottles | No intervention | UCPB group-usual care with pill bottles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing Scale (PCS)
A measure of the extent of catastrophizing
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startOct 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel-group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InCaveo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoyman Hong, MD, Principal investigator, InCaveo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836169
- Sponsor's protocol ID
- InCaveoDanielandDaniel2021
- Acronym
- P1RESPECT
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy to Lower Pain Catastrophizing Scores
- ClinicalTrials.gov ID
- NCT04836169
- Acronym / sponsor ID
- P1RESPECT / InCaveoDanielandDaniel2021
- Conditions
- Pain, Postoperative, Analgesics, Opioid
- Keywords
- pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- InCaveoIndustry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized parallel-group
| Arm | Type | Receives |
|---|---|---|
| InCaveo EOA System | Experimental | Device: InCaveo's EOA system with integrated mobile CBTInCaveo EOA System (including integrated CBT but without tapering) group |
| Control Group-usual care with pill bottles | No intervention | –UCPB group-usual care with pill bottles |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has a Pain Catastrophizing Score >16
- 55 years of age and older.
- English speaking.
- Has a smartphone (iPhone).
- Able to swallow oral medications.
Key exclusion criteria (4 listed)
- Diagnosed with Opioid Use Disorder (OUD).
- Actively using illicit drugs.
- Allergy to opioids
- Older than 85 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InCaveo's EOA system with integrated mobile CBTintegrated 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 | Device | InCaveo EOA System |
Primary outcome
Pain Catastrophizing Scale (PCS)
Time frame: 60 days
A measure of the extent of catastrophizing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoyman Hong, MD principal investigator
InCaveo
Questions about this trial
What is this clinical trial studying?
A study testing InCaveo's EOA system with integrated mobile CBT in people with Pain, Postoperative and Analgesics, Opioid, run by InCaveo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Harris, BS (8326776747, cindy@clinregconsult.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Catastrophizing Scale (PCS) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.