- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07680894
DockTales for Chronic Pain
Evaluating Feasibility and Acceptability of DockTales for Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yang Wang, PhD
- Phone Number: 410-706-7824
- Email: yang.wang@umaryland.edu
Study Locations
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-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Baltimore School of Nursing
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Principal Investigator:
- Yang Wang, PhD
-
Contact:
- Yang Wang
- Phone Number: 410-706-7824
- Email: yang.wang@umaryland.edu
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Contact:
- Rachel Massalee, MS
- Phone Number: 410-706-7824
- Email: rmassalee@umaryland.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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
|
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.
|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment rate
Time Frame: At the enrollment
|
Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
|
At the enrollment
|
|
Retention rate
Time Frame: End of Week 4
|
Retention rate: the proportion (%) of enrolled participants who finished the study
|
End of Week 4
|
|
Module completion rate
Time Frame: 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.
|
End of Week 4
|
|
Daily survey completion rate
Time Frame: End of Week 4
|
Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
|
End of Week 4
|
|
Levels of satisfaction
Time Frame: 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.
|
End of Week 2 and Week 4
|
|
Levels of enjoyment
Time Frame: 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.
|
End of Week 2 and Week 4
|
|
Levels of engagement
Time Frame: 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.
|
End of Week 2 and Week 4
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00119506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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