NCT04051216

The SMART CART Study: Health Information Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the feasibility of using two information technology tools in patients undergoing Chimeric Antigen Receptor T-cell (CART) therapy and other Cytokine Release Syndrome (CRS)-eliciting treatments such as CD123 BITE. The first is an Apple iPad® application called the BMT Roadmap, which shows information about the participant's health. The second is a wearable activity monitoring device. Health information technology tools such as Roadmap system and the activity monitoring device may enable caregivers and patients to become more active participants in their healthcare.

Detailed description

100 patients will be asked to participate in the wearable device portion of the study. 100 caregivers will be asked to participate in the Roadmap (iPad) portion of the study. Each caregiver will be provided with an iPad to use the BMT Roadmap system. Patients and/or caregivers are free to use this tool as much as they would like on their own time while in the hospital. The hospital care team will collect the iPad when the patient is discharged and ready to go home. Patients and caregivers will also be asked to take three surveys that will ask about their feelings and thoughts about the Roadmap application. The surveys will be completed when patients are admitted for their CART or other CRS-eliciting therapy, when they get discharged from the hospital and around 100 days after they receive their therapy. In addition to the use of the BMT Roadmap, this study will include around 7-10 interviews about participants' opinions on the two tools and their experience in the therapy process.

Conditions

• Leukemia, Acute
• Leukemia, Lymphoblastic

Interventions

Type	Name	Description
BEHAVIORAL	Education information system	Participants will receive a mobile tablet as an educational intervention
OTHER	Activity monitor	Participants will receive at least 1 of 4 activity monitoring devices
OTHER	Interview	Participants will be interviewed about their experience using the device(s)
OTHER	Survey Administration	Participants will receive surveys
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-12-20
• Primary completion: 2023-08-25
• Completion: 2023-11-23
• First posted: 2019-08-09
• Last updated: 2024-03-22

Locations

1 site across 1 country: United States