Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover

10. August 2026 aktualisiert von: Dharma Colgan, National University of Natural Medicine

Chronic back pain is the world's leading cause of disability, with spine surgery being a common yet costly intervention. However, many patients experience suboptimal recovery, with persistent pain and functional limitations contributing to high healthcare utilization and costs. Traditional surgical pathways often overlook the role of mental well-being and patient engagement in recovery. However, research indicates that interventions promoting self-management and stress reduction can lead to improvements in pain, faster recovery, and reduced hospital readmissions.

Evidence shows that preoperative psychosocial factors, such as anxiety and depression, significantly predict post-surgical outcomes, yet structured perioperative support is lacking. To address this gap, Ready Set Recover (RSR), a mobile health (mHealth) intervention, provides education, behavioral strategies, and psychosocial support to enhance surgical preparedness and optimize post-surgical recovery. By addressing both psychological and behavioral factors, RSR has the potential to fill a critical gap in perioperative care. As a scalable digital platform, RSR offers an accessible, cost-effective solution that can be easily integrated into existing surgical care models, reducing the burden on healthcare providers while empowering patients to take an active role in their healing process.

RSR aims to accomplish this by integrating evidence-based components such as cognitive behavioral therapy, mindfulness, gratitude practices, and guided movement to foster patient empowerment and sustainable health practices in the pre- and post-surgical periods. The platform provides patients with a structured and flexible tool to improve self-efficacy, adherence to post-surgical recommendations, and the overall surgical recovery experience.

This study aims to evaluate the feasibility and acceptability of RSR through an explanatory mixed-methods pilot randomized controlled trial (RCT) in patients undergoing medium-to-long segment spinal fusion at Oregon Health & Science University.

Aim 1 assesses feasibility and acceptability by measuring patient engagement, intervention completion rates, and satisfaction.

Aim 2 qualitatively evaluate barriers and facilitators to implementation of RSR within the clinic setting via provider, patient, and clinic stakeholder semi-structured interviews.

Aim 3 establishes a patient community advisory board (CAB) to guide future research and the development of a Phase II Small Business Technology Transfer (STTR) efficacy trial.

Findings from this study will inform the refinement and scalability of RSR as a low-burden, cost-effective solution to improve surgical outcomes. Insights gained from this research may extend beyond spine surgery, informing the development of digital health interventions for other surgical populations, ultimately advancing patient-centered, technology-driven approaches to perioperative care.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Frühphase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Ryan Wexler Assistant Research Investigator, ND, MSRC
  • Telefonnummer: 15034947377
  • E-Mail: rwexler@nunm.edu

Studieren Sie die Kontaktsicherung

  • Name: Dana Dharmakaya Colgan Assistant Professor, PhD
  • Telefonnummer: 5034947377
  • E-Mail: dcolgan@nunm.edu

Studienorte

  • Vereinigte Staaten
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97201
        • Oregon Health & Science University
        • Kontakt:
          • Dana Dharmakaya Colgan Assistant Professor, PhD
          • Telefonnummer: 15034947377
          • E-Mail: colgand@ohsu.edu
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Patients deemed candidates for medium-/long-segment spinal fusion
  • Patients who score a > 4 on a 0-10 NRS for the question "How motivated are you to participate in this research study?"
  • At least 18 years of age and not older than 80 at the time of study enrollment •Ability to read and understand English
  • Daily access to the internet via cell phone, tablet, or computer

Exclusion Criteria:

  • Have received epidural steroid injection for low back pain, lumbosacral radiculopathy, or scoliosis in the prior 3 months
  • Have received a surgical intervention for low back pain, lumbosacral radiculopathy, or scoliosis in the previous 6 months
  • Concurrent diagnosis of cancer
  • Cognitive impairment
  • Severe comorbidities (e.g., terminal illness, severe organ failure)
  • Non-elective/emergency surgery in the past

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Surgery + Standard of Care
Surgery + Standard of care is defined as instrumented spinal fusion with routine perioperative care, including preoperative information, postoperative mobilization, and standard analgesia.
Experimental: Surgery+RSR
Spinal Fusion + Ready Set Recover. Ready Set Recover is a peri-operative mHealth platform designed to help patients prepare for and recover from surgery. RSR empowers patients to be a self-advocate in their surgical journey, plan appropriately for surgery day, garner support from loved ones, and maintain healthy lifestyle practices including: spending time in nature, mindfulness practices and stress reduction, gratitude practice, and post-surgical mindful movement. These activities encourage intrinsically motivated, sustainable behavior change that supports surgical recovery.
Verhalten: Ready Set Recover
Ready Set Recover is a peri-operative mHealth platform designed to help patients prepare for and recover from surgery. RSR empowers patients to be a self-advocate in their surgical journey, plan appropriately for surgery day, garner support from loved ones, and maintain healthy lifestyle practices including: spending time in nature, mindfulness practices and stress reduction, gratitude practice, and post-surgical mindful movement. These activities encourage intrinsically motivated, sustainable behavior change that supports surgical recovery.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility of Retention
Zeitfenster: 30 days post-surgery
Measured using a participant tracking spreadsheet
30 days post-surgery
Adverse Events (AEs)
Zeitfenster: Daily from baseline through end of intervention (30 days post surgery)
The study team will regularly monitor for adverse events via the daily survey. In addition to reporting adverse events to the IRB, the investigators will regularly review adverse events at each study meeting in order to rapidly address these events and to facilitate early recognition of any emerging patterns.
Daily from baseline through end of intervention (30 days post surgery)
Feasibility of enrollment
Zeitfenster: Data collected during screening and enrollment process
Enrollment Rate: Measured using a participant tracking spreadsheet.
Data collected during screening and enrollment process
Feasibility of Adherence
Zeitfenster: Daily from baseline through end of intervention (30 days post surgery)
Measured through completion with the RSR daily actions and educational materials.
Daily from baseline through end of intervention (30 days post surgery)
Acceptability and Accessibility
Zeitfenster: 30- days post surgery
Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire.
30- days post surgery

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Visual Analog Scale for Pain Back Pain Intensity
Zeitfenster: Daily from baseline through end of intervention (30 days post surgery)
The NRS is a self-reported scale where participants will be asked to report their pain intensity on a scale from 0 to 10 (0 = "no pain", 10 = "worst pain").
Daily from baseline through end of intervention (30 days post surgery)
Modified Oswestry Disability Index (ODI)
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
Designed to assess the impact of pain on participants' ability to perform activities of daily living such as personal care, lifting, walking, and sitting. 0 to 100% (raw 0-50 points), with lower scores indicating better function.
30 Days Pre-surgery and 30 Days Post-surgery
Central Sensitization Inventory (CSI)
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
Participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization. Scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom burden.
30 Days Pre-surgery and 30 Days Post-surgery
Tampa Scale of Kinesiophobia
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The TSK-11 is designed to assess for the presence of fear of movement. Scores range from 11-44 (11 items, 4-point Likert 1 = strongly disagree to 4 = strongly agree). Higher scores indicate greater fear of movement/(re)injury
30 Days Pre-surgery and 30 Days Post-surgery
Pain Catastrophizing Scale (PCS)
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The PCS is ubiquitously used to assess pain catastrophizing via its subscales: helplessness, rumination, and magnification. Scores range from 0-52 (13 items, each 0 = not at all to 4 = all the time). Higher = greater catastrophizing.
30 Days Pre-surgery and 30 Days Post-surgery
Pain Self-efficacy Questionnaire (PSEQ)
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The PSEQ is designed to assess participants perceived ability and confidence to manage their pain. Scores range from 0-60 (10 items, 0 = not at all confident to 6 = completely confident). Higher scores indicate greater pain self-efficacy.
30 Days Pre-surgery and 30 Days Post-surgery
PROMIS Ability to Participate in Social Roles
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The ability to participate in social roles questionnaire is a PROMIS measure designed to evaluate the impact of a condition on social engagement. It uses a T-score metric, mean 50 ± 10 (US general population); practical range ~20-80 . Higher scores indicate better social participation; <40 = moderate-severe impairment.
30 Days Pre-surgery and 30 Days Post-surgery
Brief Pain Inventory (BPI)
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The BPI has previously been used to assess pain interference in patients with chronic pain and is the most frequently used measure of pain interference in trials of MORE. Scores range from 0-10 (mean of 7 items). Higher scores indicate worse interference; MCID ≥1-point improvement.
30 Days Pre-surgery and 30 Days Post-surgery
Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB):
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The PEB is designed to assess patients' beliefs about the biopsychosocial model of chronic pain. Includes 11 items, unidimensional. Higher scores indicate greater endorsement of a biopsychosocial pain model, associated with greater readiness for/engagement in self-management.
30 Days Pre-surgery and 30 Days Post-surgery
Patient Reported Outcomes Measurement Information System (PROMIS)-29:
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery

The PROMIS- 29 assesses an individual's overall quality of life using self-reporting questions in domains such as physical function, anxiety, depression, fatigue, sleep disturbance. Each of 7 domains scored as a T-score, mean 50 ± 10; plus single 0-10 pain intensity item Direction is domain-dependent. Higher scores indicate better physical function and ability to participate in social roles and activities.

Lower scores are better in anxiety, depression, fatigue, sleep disturbance, pain interference subscales.
30 Days Pre-surgery and 30 Days Post-surgery
Perioperative Anxiety Scale-7 (PAS-7)
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The peri-operative anxiety scale was developed in collaboration with psychiatrists, anesthesiologists, and surgeons to assess mental and somatic symptoms of pre-operative anxiety.
30 Days Pre-surgery and 30 Days Post-surgery
Generalized Anxiety Disorder (GAD)-7
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
The GAD-7 is a screening tool used for assessing symptoms of generalized anxiety disorder. Scores range from 0-21 (7 items, 0 = not at all to 3 = nearly every day). Higher indicates greater anxiety severity.
30 Days Pre-surgery and 30 Days Post-surgery
Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)
Zeitfenster: 30 Days Pre-surgery and 30 Days Post-surgery
MAIA-2 is designed as a tool to assess interoceptive awareness. It is made up of eight subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. Each subscale is totaled separately. Subscales are scored 0-5 (mean of items). Higher scores indicate greater interoceptive awareness.
30 Days Pre-surgery and 30 Days Post-surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National University of Natural Medicine

Mitarbeiter

Oregon Health and Science University
READY SET RECOVER, LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. September 2026

Primärer Abschluss (Geschätzt)

30. September 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

4. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. August 2026

Zuerst gepostet (Tatsächlich)

17. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Ready Set Recovery DC90325

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren