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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Other: SMART app wearable

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Principal Investigator: Nirmish Shah, MD
      • Contact: Nirmish Shah, MD; Phone Number: 919-684-8111; Email: nirmish.shah@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Patients will continue with their normal Standard of Care for their condition
Experimental: SMART app wearable device; 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').	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').

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to discontinuation of the IV PCA with opioid medication	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of movement during hospitalization		7 days
magnitude of change in pain scores		7 days
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Nirmish Shah, Duke University

Publications and helpful links

General Publications

• Vaughn J, Gollarahalli S, Shaw RJ, Docherty S, Yang Q, Malhotra C, Summers-Goeckerman E, Shah N. Mobile Health Technology for Pediatric Symptom Monitoring: A Feasibility Study. Nurs Res. 2020 Mar/Apr;69(2):142-148. doi: 10.1097/NNR.0000000000000403.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimated): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: oncology; sickle cell disease; bone marrow transplant
• Other Study ID Numbers: Pro00068979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No