Evaluating Feasibility and Acceptability of DockTales for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Module completion rate
研究概览
简要总结
This study will evaluate the feasibility and acceptability of DockTales, a mobile health tool designed for adults with chronic pain. DockTales supports pain and sleep tracking through brief diaries, body-map pain reporting, reflective journaling, visual summaries, and optional AI-supported interaction. The study will be conducted completely remotely. Participants will complete 2 weeks of DockTales use and 2 weeks of REDCap-based daily monitoring, with the order randomized. The main goal is to determine whether DockTales is usable, acceptable, engaging, and practical for adults with chronic pain compared with standard REDCap monitoring.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Both the experimenter and participants know the interventions (DockTales and REDCap). The outcome assessor will be blinded about the study conditions.
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ( 18-88 years old)
- •English speaker (written and spoken)
- •Chronic pain for at least 3 months
- •Smartphone/text messaging capability
排除标准
- •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
研究组 & 干预措施
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
干预措施: DockTales (Behavioral)
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
干预措施: REDCap monitoring (Other)
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
干预措施: DockTales (Behavioral)
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
干预措施: REDCap monitoring (Other)
结局指标
主要结局
Module completion rate
时间窗: End of Week 4
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.
Enrollment rate
时间窗: At the enrollment
Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
Retention rate
时间窗: End of Week 4
Retention rate: the proportion (%) of enrolled participants who finished the study
Daily survey completion rate
时间窗: End of Week 4
Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
Levels of satisfaction
时间窗: End of Week 2 and Week 4
Levels of satisfaction are assessed using a visual analogue scale ranging from 0 = not satisfied at all to 100 = extremely satisfied.
Levels of enjoyment
时间窗: End of Week 2 and Week 4
Levels of enjoyment are assessed using a visual analogue scale ranging from 0 = not enjoyed at all to 100 = extremely enjoyed.
Levels of engagement
时间窗: End of Week 2 and Week 4
Levels of engagement are assessed using a visual analogue scale ranging from 0 = not engaged at all to 100 = extremely engaged.
次要结局
未报告次要终点