SpinePal Open Pilot
User-Centered Development of an App-Based Cognitive-Behavioral Intervention to Reduce Persistent Opioid Use and Opioid Related Problems Following Spine Surgery
SpinePal is a self-guided digital intervention developed for patients undergoing spine surgery. The goal of this study is to learn if SpinePal is acceptable to people undergoing spine surgery. The main questions the investigators aim to answer are:
- Is the SpinePal platform considered usable and acceptable by people undergoing spine surgery?
- Is the SpinePal intervention feasible among people undergoing spine surgery?
Participants will:
- Take a screening questionnaire
- Engage with SpinePal for about 2 weeks before surgery and 4 weeks after surgery
- Wear a smartwatch
- Complete questionnaires about 4 weeks after surgery
- Complete a brief virtual interview to share feedback with the study team
Studieoversikt
Detaljert beskrivelse
SpinePal will be piloted in a sample of N = 10 patients who are scheduled to undergo lumbar or cervical spine surgery. A pre-surgery enrollment visit will occur via Zoom at least 2 weeks prior to the patient's surgery. Prior to the visit, the participant will complete screening and baseline measures. The research coordinator will then provide instructions for accessing SpinePal, including a unique user ID and password assigned to the participant. During the enrollment visit, participants will also be provided with instructions for completing physiological monitoring via a wrist-worn Garmin Vivosmart 5. The Garmin will be used to passively collect data on physiological arousal (i.e., heart rate variability), physical activity, and sleep throughout the open pilot. To enable collecting this Garmin data, the research coordinator will also assist participants with downloading and logging into a Labfront account on their smartphone.
Participants will be instructed to use SpinePal for 2-4 weeks leading up to surgery, and for at least 1 month after surgery. Participants will receive daily reminders via push notifications delivered to their smartphone. SpinePal will collect background app usage data to assess adherence and track usage of specific tools.
At 1-month postoperative, participants will receive a link to a REDCap survey including the System Usability Scale (SUS) and Client Satisfaction Questionnaire (CSQ-8), which will serve as the primary outcomes in combination with adherence based on app meta-data. Participants will also repeat surveys conducted preoperatively. The participant will then complete a 30-minute semi-structured exit interview with the research coordinator to gather additional feedback on the intervention framework, platform, content, and procedures.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03766
- Dartmouth Geisel School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 18 years or older
- English-speaking
- Able and willing to provide informed consent
- Scheduled for lumbar or cervical fusion surgery at least 2 weeks from the date of enrollment
- Owns a smartphone with reliable internet and/or data access
- Willing to engage with SpinePal and physiological monitoring via wrist-worn Garmin
Exclusion Criteria:
- Undergoing surgery for infection, malignancy, or trauma
- Undergoing isolated thoracic fusion
- Undergoing another major surgery within 3 months
- Active suicidal ideation and/or severe mental illness (e.g., psychosis)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Enhetens gjennomførbarhet
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: SpinePal
Participants will have access to SpinePal from 2 weeks before surgery through 4 weeks after surgery.
Participants can use SpinePal as much or as little as they want.
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SpinePal is a web-based app designed to support patients undergoing spine surgery.
The app includes tailored pain education, cognitive-behavioral skills, mindfulness and relaxation activities, and guided imagery exercises.
SpinePal was developed through an iterative refinement process with patients who previously underwent surgery and experienced persistent pain, impairment, and opioid use.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Usability
Tidsramme: Enrollment to the end of treatment at 1 month post-surgery
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Usability is measured by participant responses on the System Usability Scale (SUS).
The SUS score will range from 0 to 100, where higher scores indicate better usability.
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Enrollment to the end of treatment at 1 month post-surgery
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Acceptability
Tidsramme: Enrollment to the end of treatment at 1 month post-surgery
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Intervention acceptability is measured by participant responses on the Client Satisfaction Questionnaire-8 (CSQ-8).
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Enrollment to the end of treatment at 1 month post-surgery
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Feasibility
Tidsramme: Enrollment to 1 month post-surgery
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Feasibility will be assessed via app meta-data.
Engagement rates will be quantified based on the frequency and duration of interactions with the application during the clinical trial period.
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Enrollment to 1 month post-surgery
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- STUDY00033396
- 5P30DA029926-15 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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