Opioid DependenceNCT05367050
Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
A study testing Lucid Lane Therapy Program and Surgical Preparedness Course in people with Opioid Dependence and Opioid Use, run by Lucid Lane, Inc at 1 site in United States.
Trial summary
The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Opioid Dependence, Opioid Use, Pain, Joint
- What is being tested?
- Lucid Lane Therapy Program and Surgical Preparedness Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to Apr 2023
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between the ages of 21-90 years old
- Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
- Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
- Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
- Patient is willing to sign a Lucid Lane Client Agreement.
- Patient is willing to sign an informed consent form
Who cannot join
- Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
- Active suicidal ideations
- Patient is on methadone or buprenorphine for treatment of opioid use disorder(i.e. for treatment of addiction, and not for treatment of pain)
- Patient unwilling to use or not possessing access to a device that allows for video visits(e.g. a smart phone, tablet, or computer)
- Patients who are in palliative care
- Unable to use English to participate in the consent process, the intervention or study assessments.
- Unable to provide informed consent to participate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Palo Alto Division - VA Palo Alto Health Care System
Palo Alto, California, 94304
Kyle T Harrison, MD, 650-996-6532, kharriso@stanford.edu
Nithya Vijayakumar, MS, 6505146117, NVijayakumar@pavir.org
About this study
Official title: Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids.
The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.
- Conditions
- Opioid Dependence, Opioid Use, Pain, Joint
- Being tested
- Lucid Lane Therapy Program, Surgical Preparedness Course
- Medical subject headings
- Opioid-Related Disorders, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucid Lane Therapy ProgramBehavioural
This intervention is designed to aid participants with pre-surgery anxiety management and surgery prep and pain management post-surgery. Participants will be assigned a Lucid Lane pain coach who will utilize mindfulness, cognitive behavioral therapy, group therapy, and mind-body therapies, to accomplish those goals.
Surgical Preparedness CourseBehavioural
This intervention is designed to help the participant prepare for their upcoming surgery. Classes will include discussions around managing chronic pain before surgery, building mental resilience, dealing with the uncertainty of a new diagnosis or treatment plan, questions to ask their anesthesiologist before and on the day of surgery, what to expect during their potential stay at the hospital, and how to optimize their recovery after surgery. Sessions will often include expert doctors who focus on surgery and medical management around it.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Patients participate in the Lucid Lane therapy program including working with a mental health pain coach for up to 4 weeks before surgery and 4 weeks after surgery.
All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery Receives: Behavioral: Lucid Lane Therapy Program |
| Control | Active comparator | Patients will participate in a a surgery preparedness course provided by the VA before surgery (Standard of Care) and Lucid Lane therapy after surgery
All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery Receives: Behavioral: Lucid Lane Therapy Program; Behavioral: Surgical Preparedness Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
The KOOS and HOOS are questionnaires designed to assess short and long-term patient-relevant outcomes following knee/hip injury. They are self-administered and assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee/hip-related quality of life. The scores are normalized on a scale of 0 to 100, where 0 indicates severe problems and 100 indicates no problems.
Measured: Up to 4 months
Change in Pain Catastrophizing scale
The Pain catastrophizing scale (PCS) is a self administered, 13-item questionnaire, used to assess a patient's tendency to magnify the threat value of a pain stimulus. It assess rumination, magnification and helplessness. Responses are recorded on a scale of 0-4, where 0 represents absence of the thought and 4 represents the presence of the thought all the time. The scale has a min score of 0 and a max score of 52. A higher score indicates more pain catastrophizing .
Measured: Up to 4 months
Change in Depression Scores
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self administered questionnaire used to screen and monitor the severity of depressive symptoms. It inquires about depressive features, that align with the diagnostic and statistical manual of mental disorders, over the course of 2 weeks. Responses are recorded on a scale of 0-3, where 0 represents absence of the symptom and 3 represents its presence nearly every day.
Measured: Up to 4 months
Change in Anxiety Scores
The General Anxiety Disorder-7 (GAD-7) is a self administered, 7-item questionnaire used to measure general anxiety disorder and its severity. Responses are recorded on a scale of 0-3, where 0 represents an absence of the symptom and 3 represents presence nearly every day.
Measured: Up to 4 months
Secondary outcomes (1)
Percent tapered off opioid (50% MME)
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start4 May 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucid Lane, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, VA Palo Alto Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367050
- Sponsor's protocol ID
- 56984
- Status last verified
- May 2022
- First submitted
- 22 Apr 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids.
- ClinicalTrials.gov ID
- NCT05367050
- Acronym / sponsor ID
- 56984
- Conditions
- Opioid Dependence, Opioid Use, Pain, Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Lucid Lane, IncIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University, VA Palo Alto Health Care System
- Study start
- 4 May 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 10 May 2022 (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 quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Behavioral: Lucid Lane Therapy ProgramPatients participate in the Lucid Lane therapy program including working with a mental health pain coach for up to 4 weeks before surgery and 4 weeks after surgery. All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery |
| Control | Active comparator | Behavioral: Lucid Lane Therapy Program, Behavioral: Surgical Preparedness CoursePatients will participate in a a surgery preparedness course provided by the VA before surgery (Standard of Care) and Lucid Lane therapy after surgery All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients between the ages of 21-90 years old
- Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
- Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
- Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
- Patient is willing to sign a Lucid Lane Client Agreement.
Key exclusion criteria (7 listed)
- Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
- Active suicidal ideations
- Patient is on methadone or buprenorphine for treatment of opioid use disorder(i.e. for treatment of addiction, and not for treatment of pain)
- Patient unwilling to use or not possessing access to a device that allows for video visits(e.g. a smart phone, tablet, or computer)
- Patients who are in palliative care
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 |
|---|---|---|
| Lucid Lane Therapy ProgramThis intervention is designed to aid participants with pre-surgery anxiety management and surgery prep and pain management post-surgery. Participants will be assigned a Lucid Lane pain coach who will utilize mindfulness, cognitive behavioral therapy, group therapy, and mind-body therapies, to accomplish those goals. | Behavioural | Control, Treatment |
| Surgical Preparedness CourseThis intervention is designed to help the participant prepare for their upcoming surgery. Classes will include discussions around managing chronic pain before surgery, building mental resilience, dealing with the uncertainty of a new diagnosis or treatment plan, questions to ask their anesthesiologist before and on the day of surgery, what to expect during their potential stay at the hospital, and how to optimize their recovery after surgery. Sessions will often include expert doctors who focus on surgery and medical management around it. | Behavioural | Control |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
Time frame: Up to 4 months
The KOOS and HOOS are questionnaires designed to assess short and long-term patient-relevant outcomes following knee/hip injury. They are self-administered and assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee/hip-related quality of life. The scores are normalized on a scale of 0 to 100, where 0 indicates severe problems and 100 indicates no problems.
Change in Pain Catastrophizing scale
Time frame: Up to 4 months
The Pain catastrophizing scale (PCS) is a self administered, 13-item questionnaire, used to assess a patient's tendency to magnify the threat value of a pain stimulus. It assess rumination, magnification and helplessness. Responses are recorded on a scale of 0-4, where 0 represents absence of the thought and 4 represents the presence of the thought all the time. The scale has a min score of 0 and a max score of 52. A higher score indicates more pain catastrophizing .
Change in Depression Scores
Time frame: Up to 4 months
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self administered questionnaire used to screen and monitor the severity of depressive symptoms. It inquires about depressive features, that align with the diagnostic and statistical manual of mental disorders, over the course of 2 weeks. Responses are recorded on a scale of 0-3, where 0 represents absence of the symptom and 3 represents its presence nearly every day.
Change in Anxiety Scores
Time frame: Up to 4 months
The General Anxiety Disorder-7 (GAD-7) is a self administered, 7-item questionnaire used to measure general anxiety disorder and its severity. Responses are recorded on a scale of 0-3, where 0 represents an absence of the symptom and 3 represents presence nearly every day.
1 secondary outcome
Percent tapered off opioid (50% MME)
Time frame: 4 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
Palo Alto Division - VA Palo Alto Health Care System
Palo Alto, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lucid Lane Therapy Program and Surgical Preparedness Course in people with Opioid Dependence and Opioid Use, run by Lucid Lane, Inc at 1 site in United States.
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 6 inclusion and 7 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and (time frame: Up to 4 months). The study lists 4 primary outcomes in all. 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 10 May 2022.