Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DockTales first | Other | 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 |
|
| REDCap first | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DockTales | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | Enrollment rate: the proportion (%) of recruited participants who enrolled in the study. | At the enrollment |
| Retention rate | Retention rate: the proportion (%) of enrolled participants who finished the study | End of Week 4 |
| Module completion rate | 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. | End of Week 4 |
| Daily survey completion rate | Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys. | End of Week 4 |
| Levels of satisfaction | Levels of satisfaction are assessed using a visual analogue scale ranging from 0 = not satisfied at all to 100 = extremely satisfied. | End of Week 2 and Week 4 |
| Levels of enjoyment | Levels of enjoyment are assessed using a visual analogue scale ranging from 0 = not enjoyed at all to 100 = extremely enjoyed. | End of Week 2 and Week 4 |
| Levels of engagement | Levels of engagement are assessed using a visual analogue scale ranging from 0 = not engaged at all to 100 = extremely engaged. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wang, PhD | Contact | 410-706-7824 | yang.wang@umaryland.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Baltimore School of Nursing | Baltimore | Maryland | 21201 | United States |
The study team has not yet determined whether individual participant data will be shared. This pilot study will collect sensitive health-related data and DockTales free-text interaction data, which may inadvertently include identifiable information. Any future sharing would be limited to de-identified data, would exclude direct identifiers and raw free-text data unless appropriately redacted, and would occur only after IRB approval and in accordance with institutional policies.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
All participants will complete 2 weeks of DockTales use and 2 weeks of REDCap standard monitoring.
Not provided
Not provided
Both the experimenter and participants know the interventions (DockTales and REDCap). The outcome assessor will be blinded about the study conditions.
|
| REDCap monitoring | Other | REDCap will be used to monitor daily symptoms and diaries from people with chronic pain. |
|
| End of Week 2 and Week 4 |