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UControlPain App (This is the Official IRB Title)

NCT03833648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-09-30

No results posted yet for this study

Summary

It is estimated that 77% of all Americans own a smartphone and the use of health apps has doubled in the last two years. Consistent with this development, over half of US smartphone owners have downloaded a health-related mobile app. While patient engagement is an integral and well-established component of in-hospital Early Recovery After Surgery (ERAS) programs that drive improved perioperative outcomes, efforts to support such engagement are often limited to a patient's hospital stay. The objective of this aim is to empower patients to control their use of pain medications after surgery in a safe and effective fashion using a novel and innovative consumer health informatics app: UControlPain. This app will be leveraged to integrate three critical components of the study into one application: First, study recruitment and consent documentation. Second, application of the intervention engaging patients to take control of their pain management after discharge. Lastly, UControlPain will collect relevant patient outcomes including pain assessments, functional status, and quantification of opioid and non-opioid analgesic medication intake. Use of the app will reduce the amount of opioid medication required, while enhancing patient post-operative pain control by maximizing non-opioid therapy. Subjects will be able to employ flexible non-opioid therapy with acetaminophen and NSAIDs whenever possible and safe. The rationale is that testing of such a provider-prescribed consumer health informatics app (UControlPain) will lay the groundwork to scale this project towards more secure and efficient pain management practices after surgery on a systems level and beyond. Upon completion, the expectation is to have developed an effective consumer health informatics app to help patients better manage their post-surgical pain at home, reduce reliance on opioids, and improve opioid safety through enhanced storage and disposal behaviors.

Conditions

  • Opioid Use

Interventions

OTHER

UControl Pain App with Education

The intervention will include educational information on pain management, e.g., using acetaminophen and NSAIDs to manage pain, as well as information on addiction and safe storage of medications.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Karsten Bartels, MD, PhD · CU Anschutz Medical Campus

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2020-04-20
Completion
2020-04-20

Countries

  • United States

Study Locations

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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 NCT03833648 on ClinicalTrials.gov