CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 215 enrolled
Drug / intervention
Trialist Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02116621
NCT02116621N/ACompleted

N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)

University of California, Davis·interventional·Posted Apr 17, 2014·Updated May 25, 2018

In Brief

A clinical study evaluating Trialist Intervention and smartphone for Musculoskeletal Pain and Chronic Pain. Completed, enrolled 215 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 17, 2014
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2017
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.2 years ago

Interventions

Trialist Interventionbehavioral

Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.

smartphonedevice