SpinePal Open Pilot

Trustees of Dartmouth College

Status: Invitation-only

Conditions: Spine Surgery

Treatments: Device: SpinePal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07737912

5P30DA029926-15 (U.S. NIH Grant/Contract)

STUDY00033396

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SpinePal

Experimental group

Description:

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.

Treatment:

Device: SpinePal