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N-of-1 Trials Using mHealth in Chronic Pain

NCT02116621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2018-05-25

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Trialist Intervention

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.

DEVICE

smartphone

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Richard L Kravitz, MD, MSPH · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-02-01
Completion
2017-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116621 on ClinicalTrials.gov