DockTales for Chronic Pain
Evaluating Feasibility and Acceptability of DockTales for Chronic Pain
研究概览
详细说明
This is a fully remote, randomized crossover pilot clinical trial designed to evaluate the feasibility and acceptability of DockTales among adults with chronic pain. Chronic pain is defined as pain lasting for more than 3 months. A total of up to 60 participants will be enrolled.
Participants will be randomized in a 1:1 ratio to one of two study sequences. Participants assigned to Sequence 1 will complete 2 weeks of DockTales use followed by 2 weeks of REDCap-based daily monitoring. Participants assigned to Sequence 2 will complete 2 weeks of REDCap-based daily monitoring followed by 2 weeks of DockTales use. All participants will complete both study conditions.
Participants will complete questionnaires at baseline, after the first 2-week period, and after the second 2-week period. These assessments will evaluate feasibility, acceptability, usability, burden, engagement, technical issues, participant preference, and exploratory pain and sleep-related outcomes. Some participants may also complete an optional remote semi-structured interview after finishing both study conditions.
The primary outcomes are feasibility and acceptability. Feasibility will be assessed through recruitment, retention, adherence, completion of DockTales use, completion of REDCap monitoring, missing data, and technical issues. Acceptability will be assessed through satisfaction, engagement, perceived usefulness, ease of use, burden, willingness to use DockTales again, and preference between DockTales and REDCap monitoring.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yang Wang, PhD
- 电话号码：410-706-7824
- 邮箱：yang.wang@umaryland.edu
学习地点
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland Baltimore School of Nursing
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首席研究员：
- Yang Wang, PhD
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接触：
- Yang Wang
- 电话号码：410-706-7824
- 邮箱：yang.wang@umaryland.edu
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接触：
- Rachel Massalee, MS
- 电话号码：410-706-7824
- 邮箱：rmassalee@umaryland.edu
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age ( 18-88 years old)
- English speaker (written and spoken)
- Chronic pain for at least 3 months
- Smartphone/text messaging capability
Exclusion Criteria:
- Any personal history of mania, schizophrenia, or other psychoses
- Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
- Pregnancy or breast feeding
- Impaired or uncorrected hearing
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：DockTales first
This is a crossover-designed study with one arm of chronic pain participants.
All participants will complete both active (DockTales) and control (REDCap) interventions in a randomized sequence.
The first arm will complete 2 weeks of DockTales first, and 2 weeks of REDCap monitoring
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DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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其他：REDCap first
This is a crossover-designed study.
Participants in this arm will start with 2 weeks of REDCap monitoring, followed by 2 weeks of DockTales use
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DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Enrollment rate
大体时间：At the enrollment
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Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
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At the enrollment
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Retention rate
大体时间：End of Week 4
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Retention rate: the proportion (%) of enrolled participants who finished the study
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End of Week 4
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Module completion rate
大体时间：End of Week 4
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Module rate: the proportion (%) of completed modules in the DockTales app.
The DockTales app contains 1) daily monitoring module; 2) navigation map module; 3) AI avatar companion module; and 4) daily dairy module.
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End of Week 4
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Daily survey completion rate
大体时间：End of Week 4
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Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
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End of Week 4
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Levels of satisfaction
大体时间：End of Week 2 and Week 4
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Levels of satisfaction are assessed using a visual analogue scale ranging from 0 = not satisfied at all to 100 = extremely satisfied.
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End of Week 2 and Week 4
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Levels of enjoyment
大体时间：End of Week 2 and Week 4
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Levels of enjoyment are assessed using a visual analogue scale ranging from 0 = not enjoyed at all to 100 = extremely enjoyed.
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End of Week 2 and Week 4
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Levels of engagement
大体时间：End of Week 2 and Week 4
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Levels of engagement are assessed using a visual analogue scale ranging from 0 = not engaged at all to 100 = extremely engaged.
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End of Week 2 and Week 4
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HP-00119506
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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