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NCT02116621 · ClinicalTrials.gov registry record · NA
N-of-1 Trials Using mHealth in Chronic Pain
A NA study, sponsored by University of California, Davis.
- Completed
- Registry status
- NA
- Development phase
- 215
- Enrollment target
NCT02116621: Completed NA study, sponsored by University of California, Davis.
NCT02116621 is a NA study that has completed, run by University of California, Davis. The registered enrollment target is 215 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02116621, a NA study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
Study Summary
Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The disadvantage to this method is that it may take a long time to find a successful treatment. The purpose of the PREEMPT Study is to test whether using a mobile phone application ("Trialist app") that allows patients and their health care providers to run personalized experiments comparing two pain treatments is more effective than usual care. Patients download the app, and working with their clinicians, set up a personalized trial that makes sense for them. Every day they answer questions to track levels of pain and side effects of treatment, such as fatigue and constipation. Once the personalized trial has ended, the responses to these daily questions on each treatment will be compared. During a regular clinic visit, the patient and the clinician will review visual displays of the results to facilitate treatment decision-making. Approximately 250 patients will be enrolled in the study. Half the patients will use the app and review results with the clinician, and half the patients will continue with their regular care (i.e., will not use the app). The two groups will be compared to see if using the app is successful in improving long term pain outcomes. The goal of the intervention using the Trialist app is to help patients engage actively and collaboratively with their clinicians and identify effective treatments more quickly.
Primary Outcome
Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change
Interventions
- BEHAVIORAL Trialist Intervention
- DEVICE smartphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-05-01 |
| Phase | NA |
What the finished NCT02116621 record still lists
NCT02116621 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Trialist Intervention is the first listed.
NCT02116621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02116621 about?
NCT02116621 is a clinical study titled "N-of-1 Trials Using mHealth in Chronic Pain". Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The dis...
What is the current status of trial NCT02116621?
This trial is currently completed. It is a NA study. The enrollment target is 215 participants. The study started on 2014-07. Estimated completion is 2017-05-01.
What interventions are being tested in trial NCT02116621?
The interventions under investigation include: Trialist Intervention (BEHAVIORAL), smartphone (DEVICE).
Who is sponsoring clinical trial NCT02116621?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02116621's enrollment target sits among peer trials
215 487th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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