The SMART CART Study: Health Information Technology
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|ClinicalTrials.gov Identifier: NCT04051216|
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Acute Leukemia, Lymphoblastic||Behavioral: Education information system Other: Activity monitor Other: Interview Other: Survey Administration Other: Laboratory Biomarker Analysis||Not Applicable|
30 patients will be asked to participate in the wearable device portion of the study. 30 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 therapy, when they get discharged from the hospital and around 100 days after they receive their CART 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 CART therapy process.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The SMART CART Study: Health Information Technology|
|Actual Study Start Date :||December 20, 2017|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Supportive Care
Caregivers receive the Roadmap information system loaded on an Apple iPad® for use during the inpatient hospitalization of CART therapy. The Roadmap information system consists of 5 modules personalized to the CART patient: laboratory studies, medications, clinical trial enrollment, healthcare providers, and criteria for discharge. Patients wear an activity monitoring device on days 0-100. Patients wear the device as long as they can each day to monitor physical activity level, sleep/wake patterns, skin temperature, heart rate and respiratory rate.
Behavioral: Education information system
Participants will receive a mobile tablet as an educational intervention
Other Name: Roadmap information system
Other: Activity monitor
Participants will receive at least 1 of 4 activity monitoring devices
Participants will be interviewed about their experience using the device(s)
Other: Survey Administration
Participants will receive surveys
Other: Laboratory Biomarker Analysis
- Percentage of caregivers that log onto the BMT Roadmap at least once per day for a minimum of 4 of the 7 days of the week while the patient is in the hospital. [ Time Frame: Duration of hospital admission, up to ~6 weeks ]To test the feasibility of implementing the system in the pediatric CART population. This aim will be measured quantitatively by the log-use data.
- Percentage of patients who are able to wear the activity monitoring device(s) approximately 12 hours of the day. [ Time Frame: Up to day 100 post-CART ]To test the feasibility of implementing a non-invasive, wearable activity monitoring device in the pediatric CART population. This aim will be measured quantitatively by the log-use data.
- Percentage of patients from whom longitudinal samples of blood, urine and stool are collected, for correlative studies. [ Time Frame: Up to day 100 post-CART ]Feasibility of collecting longitudinal samples of blood, urine and stool from study population. Samples will be used to perform an exploratory analysis of the relationship between these biomarkers and clinical status, Roadmap and wearable device information.
- Caregiver activation/participation compared to reference population to measure the impact of Roadmap information system and wearable monitoring device using survey instrument scores of Parent-Patient Activation Measure (P-PAM) as a composite measure. [ Time Frame: Up to day 100 post-CART ]Descriptive statistics will be calculated for each Patient Activation Measure (PAM) score and stratified into the appropriate level of activation. Results will be compared with a published sample. Univariate analyses will be performed to assess associations between PAM and demographic, social, and environmental characteristics of the parent (type of insurance, marital status, number of children in household), disease-related characteristics of the patients (age, disease, disease status at CART), satisfaction (Press Ganey, Usefulness), caregiver burden (CQOLC), mood (POMS), anxiety (STAI), stress (Impact of Event Scale-Revised), miscarried helping (HHI), and experiential avoidance (PAAQ). Pearson's correlation (and other suitable measures of association for categorical variables) will be used to determine the nature and significance of association between each variable and Parent-PAM scores. This analysis will not be powered to detect any statistically meaningful differences.
- Care providers' satisfaction with the Roadmap information system and non-invasive, wearable activity monitoring device health IT tools for patients and their families/caregivers. [ Time Frame: Up to day 100 post-CART ]Qualitative interviews of BMT healthcare providers (physicians, nurses, advanced practitioners, social workers, psychologist, nutritionist, and pharmacologist). This is information gathering only. There is no reference population for this.
- Presence of care process redesign associated with the Roadmap information system and wearable monitoring devices. [ Time Frame: Up to day 100 post-CART ]Measured qualitatively by semi-structured qualitative interviews.
- Quality of care process redesign associated with the Roadmap information system and wearable monitoring devices. [ Time Frame: Up to day 100 post-CART ]Measured qualitatively by semi-structured qualitative interviews.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051216
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Sung Won Choi, MD, MS||University of Michigan|