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

• ClinicalTrials.gov Identifier: NCT02895841
• Recruitment Status: Recruiting
• First Posted: September 12, 2016
• Last Update Posted: January 26, 2023
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: September 1, 2016
• First Posted Date: September 12, 2016
• Last Update Posted Date: January 26, 2023
• Study Start Date: August 2016
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 6, 2016): time to discontinuation of the IV PCA with opioid medication [ Time Frame: 7 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2016)

• time of movement during hospitalization [ Time Frame: 7 days ]
• magnitude of change in pain scores [ Time Frame: 7 days ]
• patient/family satisfaction scores as measured by feasibility survey [ Time Frame: 7 days ]
  A 24-item survey was developed for parents and children assessing technical feasibility, adherence

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Patient-Empowered Mobile Technology in Hospitalized Patients (TRU-PAIN)
• Official Title: Patient-Empowered Mobile Technology in Hospitalized Patients: Technology Resources to Understand Pain Assessment in Patients With Pain (TRU-PAIN)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: 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').

Study Arms

• 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').
  Intervention: Other: SMART app wearable

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 6, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02895841
• Other Study ID Numbers: Pro00068979
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nirmish Shah; Duke University

• PRS Account: Duke University
• Verification Date: January 2023