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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Hampshire
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Lebanon, New Hampshire, 미국, 03766
- Dartmouth Geisel School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Usability
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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