Menu
Not yet recruiting NCT07680894

DockTales for Chronic Pain

No phase Interventional Chronic Pain Chronic Pain Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DockTales, REDCap monitoring.
Who it may be relevant to
Registry conditions: Chronic Pain, Chronic Pain Syndrome. Basic parameters: 18 years — 88 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating Feasibility and Acceptability of DockTales for Chronic Pain

Overview

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

  • Behavioral DockTales
    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.
  • Other REDCap monitoring
    REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.

Primary outcome measures

  • Enrollment rate [Time frame: At the enrollment]
  • Retention rate [Time frame: End of Week 4]
  • Module completion rate [Time frame: End of Week 4]
  • Daily survey completion rate [Time frame: End of Week 4]
  • Levels of satisfaction [Time frame: End of Week 2 and Week 4]
  • Levels of enjoyment [Time frame: End of Week 2 and Week 4]
  • Levels of engagement [Time frame: End of Week 2 and Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Maryland Baltimore School of Nursing — Baltimore

Identifiers

NCT: NCT07680894 · HP-00119506

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗