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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03766
- Dartmouth Geisel School of Medicine
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Usability
Periodo de tiempo: Enrollment to the end of treatment at 1 month post-surgery
|
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
Periodo de tiempo: Enrollment to the end of treatment at 1 month post-surgery
|
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
Periodo de tiempo: Enrollment to 1 month post-surgery
|
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.
|
Enrollment to 1 month post-surgery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00033396
- 5P30DA029926-15 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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