Patient-Empowered Mobile Technology in Hospitalized Patients (TRU-PAIN)

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895841
• Other study ID #: Pro00068979
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 22, 2024

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• SMART app wearable
Patients will be given a wearable such as a Microsoft Band accelerometer to track movement, heart rate, galvanic skin response and sleep, which will be collected in combination with the data from the SMART visual dashboard. Data will be sent to the SMART dashboard as well as stored on the iPad/iPod touch via software from the manufacturer. Participants having a "wearable device" will receive the education intervention (such as haptic prompted texts that state 'try and walk today', 'have you had enough water today', 'make sure to take deep breaths').

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to discontinuation of the IV PCA with opioid medication		7 days
Secondary	time of movement during hospitalization		7 days
Secondary	magnitude of change in pain scores		7 days
Secondary	patient/family satisfaction scores as measured by feasibility survey	A 24-item survey was developed for parents and children assessing technical feasibility, adherence	7 days