- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05367050
Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
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Palo Alto, California, Forenede Stater, 94304
- Rekruttering
- Palo Alto Division - VA Palo Alto Health Care System
-
Kontakt:
- Kyle T Harrison, MD
- Telefonnummer: 650-996-6532
- E-mail: kharriso@stanford.edu
-
Kontakt:
- Nithya Vijayakumar, MS
- Telefonnummer: 6505146117
- E-mail: NVijayakumar@pavir.org
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Ledende efterforsker:
- Kyle T Harrison, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Treatment
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 |
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.
|
Aktiv komparator: Control
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 |
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.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
Tidsramme: 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.
|
Up to 4 months
|
Change in Pain Catastrophizing scale
Tidsramme: 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 .
|
Up to 4 months
|
Change in Depression Scores
Tidsramme: 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.
|
Up to 4 months
|
Change in Anxiety Scores
Tidsramme: 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.
|
Up to 4 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent tapered off opioid (50% MME)
Tidsramme: 4 weeks after surgery
|
4 weeks after surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 56984
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-
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-
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