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Clinical Trials/NCT02895841
NCT02895841
Completed
N/A

Patient-Empowered Mobile Technology in Hospitalized Patients: Technology Resources to Understand Pain Assessment in Patients With Pain (TRU-PAIN)

Duke University1 site in 1 country174 target enrollmentAugust 2016
ConditionsPain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Duke University
Enrollment
174
Locations
1
Primary Endpoint
time to discontinuation of the IV PCA with opioid medication
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to learn more about the ways in which mobile technology can be integrated into inpatient care to help better track pain levels using mobile technology of patients with sickle cell disease, oncology patients, and bone marrow transplant patients. The study will assess whether or not daily mobile monitoring with wearable accelerometers (devices that detect movement as well as heart-rate) to monitor and manage medical treatments can have a lasting positive impact on outcomes in patients with chronic diseases. The investigator hopes to learn more about the ways in which mobile technology can be integrated into inpatient care. Specifically, the investigator is looking to help patients better track their pain, use wearable technology to track physiological measures (for example, heart rate, sleep quantity and quality), and integrate these data points into the medical care of patients by providing the information to providers. This study will first gather information regarding the feasibility and acceptability of the use of technology on the inpatient unit. This will help the study team to refine the technology of the mobile app and logistics of integration. Following this, the investigator will complete a second phase of the study, during which select patients will pilot the intervention. This will be followed by the third and final phase, during which patients will be randomly assigned to the active intervention or standard of care. This phase approach will enable the study team to refine the intervention, relying on the feedback from patients and providers, and subsequently test its utility compared to standard of care through random assignment.

Detailed Description

The investigator hopes to learn more about the ways in which mobile technology can be integrated into inpatient care. Specifically, the investigator is looking to help patients better track their pain, use wearable technology to track physiological measures (for example, heart rate, sleep quantity and quality), and integrate these data points into the medical care of patients by providing the information to providers. This study will first gather information regarding the feasibility and acceptability of the use of technology on the inpatient unit. This will help the study team to refine the technology of the mobile app and logistics of integration. Following this, the investigator will complete a second phase of the study, during which select patients will pilot the intervention. This will be followed by the third and final phase, during which patients will be randomly assigned to the active intervention or standard of care. This phase approach will enable the study team to refine the intervention, relying on the feedback from patients and providers, and subsequently test its utility compared to standard of care through random assignment.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
April 22, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Any patient 8-80 years old with a past medical history for a chronic disease (such as sickle cell disease), cancer (solid tumor, lymphoma, brain tumor), or currently undergoing bone marrow transplant
  • Currently admitted to the hospital
  • Have a current diagnosis which includes pain for which they are being treated

Exclusion Criteria

  • Must be enrolled within 48 hours of admission
  • Due to the possibility of a choking hazard, only patients who are at least 8 years of age will be enrolled in the study
  • Patients in the Intensive Care Units will not be eligible
  • Must be able to understand and operate the mobile device independently; therefore the investigators will exclude those the provider team considers unable to do so

Outcomes

Primary Outcomes

time to discontinuation of the IV PCA with opioid medication

Time Frame: 7 days

Secondary Outcomes

  • time of movement during hospitalization(7 days)
  • magnitude of change in pain scores(7 days)
  • patient/family satisfaction scores as measured by feasibility survey(7 days)

Study Sites (1)

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