Chronic Pain, Chronic Pain Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDockTales
DockTales includes several core features: 1. Brief diary entries 2. Body-map pain reporting/feedback 3. Reflective journaling 4. Optional AI-supported interaction The AI-supported feature is not intended to provide medical advice, diagnosis, treatment recommendations, mental health care, or emergency support. The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
OTHERREDCap monitoring
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Both the experimenter and participants know the interventions (DockTales and REDCap). The outcome assessor will be blinded about the study conditions.
Intervention model description
All participants will complete 2 weeks of DockTales use and 2 weeks of REDCap standard monitoring.
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | At the enrollment | Enrollment rate: the proportion (%) of recruited participants who enrolled in the study. |
| Retention rate | End of Week 4 | Retention rate: the proportion (%) of enrolled participants who finished the study |
| Module completion rate | 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. |
| Daily survey completion rate | End of Week 4 | Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys. |
| Levels of satisfaction | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTYang Wang, PhD
Outcome results
None listed