NCT04094844

Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation

A Randomized Trial of Roadmap 2.0

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 5 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to measure the effects of using a mobile phone app (Roadmap 2.0) on the health-related quality of life of caregivers and patients undergoing allogeneic/autologous hematopoietic cell transplantation (HCT).

Detailed description

Health information technology tools may enable caregivers and patients to become more active participants in their healthcare.This study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0). Roadmap 2.0 is a web-based application that integrates patient-specific information and includes several domains: laboratory results, medications, clinical trial details, photos of the healthcare team, trajectory of transplant process, and discharge checklist. This trial is anticipated to enroll 664 participants, but only caregivers (332 total) will be evaluated for the primary and secondary outcome measures. Thus, the sample size is 332. The total enrollment includes 166 caregiver-patient dyads of adult patients (age \>/=18 years) undergoing HCT ("adult dyads" = 332 total) and 166 caregiver-patient dyads of pediatric patients (age 5-17 years) undergoing HCT ("pediatric dyads" = 332 total).

Conditions

• Hematologic Diseases

Interventions

Type	Name	Description
OTHER	Wearable activity sensor	Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
BEHAVIORAL	Roadmap 2.0 information system	Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
OTHER	Survey administration	Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
BEHAVIORAL	Roadmap 2.0 information system with Positive Activities	Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay.

Timeline

• Start date: 2020-09-08
• Primary completion: 2024-08-11
• Completion: 2024-08-11
• First posted: 2019-09-19
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

2 sites across 1 country: United States