Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover
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.
調査の概要
状態
条件
介入・治療
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Ryan Wexler Assistant Research Investigator, ND, MSRC
- 電話番号：15034947377
- メール：rwexler@nunm.edu
研究連絡先のバックアップ
- 名前：Dana Dharmakaya Colgan Assistant Professor, PhD
- 電話番号：5034947377
- メール：dcolgan@nunm.edu
研究場所
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Oregon
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Portland、Oregon、アメリカ、97201
- Oregon Health & Science University
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コンタクト：
- Dana Dharmakaya Colgan Assistant Professor, PhD
- 電話番号：15034947377
- メール：colgand@ohsu.edu
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コンタクト：
- Ryan Wexler, ND, MSCR
- 電話番号：5034947377
- メール：rwexler@nunm.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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.
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実験的：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.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of Retention
時間枠：30 days post-surgery
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Measured using a participant tracking spreadsheet
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30 days post-surgery
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Adverse Events (AEs)
時間枠：Daily from baseline through end of intervention (30 days post surgery)
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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.
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Daily from baseline through end of intervention (30 days post surgery)
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Feasibility of enrollment
時間枠：Data collected during screening and enrollment process
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Enrollment Rate: Measured using a participant tracking spreadsheet.
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Data collected during screening and enrollment process
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Feasibility of Adherence
時間枠：Daily from baseline through end of intervention (30 days post surgery)
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Measured through completion with the RSR daily actions and educational materials.
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Daily from baseline through end of intervention (30 days post surgery)
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Acceptability and Accessibility
時間枠：30- days post surgery
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Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire.
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30- days post surgery
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Visual Analog Scale for Pain Back Pain Intensity
時間枠：Daily from baseline through end of intervention (30 days post surgery)
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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").
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Daily from baseline through end of intervention (30 days post surgery)
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Modified Oswestry Disability Index (ODI)
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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Central Sensitization Inventory (CSI)
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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Tampa Scale of Kinesiophobia
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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
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30 Days Pre-surgery and 30 Days Post-surgery
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Pain Catastrophizing Scale (PCS)
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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Pain Self-efficacy Questionnaire (PSEQ)
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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PROMIS Ability to Participate in Social Roles
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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Brief Pain Inventory (BPI)
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB):
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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Patient Reported Outcomes Measurement Information System (PROMIS)-29:
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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
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Perioperative Anxiety Scale-7 (PAS-7)
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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The peri-operative anxiety scale was developed in collaboration with psychiatrists, anesthesiologists, and surgeons to assess mental and somatic symptoms of pre-operative anxiety.
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30 Days Pre-surgery and 30 Days Post-surgery
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Generalized Anxiety Disorder (GAD)-7
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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.
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30 Days Pre-surgery and 30 Days Post-surgery
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Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)
時間枠：30 Days Pre-surgery and 30 Days Post-surgery
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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
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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