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

Not Applicable

Completed

• Conditions: Hematologic Diseases
• Interventions: Other: Wearable activity sensor; Behavioral: Roadmap 2.0 information system; Other: Survey administration; Behavioral: Roadmap 2.0 information system with Positive Activities

• Registration Number: NCT04094844
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief 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).

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-19
• Study Start: 2020-09-08
• Primary Completion: 2024-08-11
• Study Completion: 2024-08-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roadmap 2.0	Wearable activity sensor	Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients
Roadmap 2.0 with Positive Activities	Wearable activity sensor	Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients
Roadmap 2.0	Roadmap 2.0 information system	Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients
Roadmap 2.0	Survey administration	Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients
Roadmap 2.0 with Positive Activities	Survey administration	Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients
Roadmap 2.0 with Positive Activities	Roadmap 2.0 information system with Positive Activities	Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials). Includes caregivers of adult patients and caregivers of pediatric patients

Primary Outcome Measures

Name	Time	Method
Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale.	At day 120 post-transplant	Mean Global Health scores for each arm at day 120. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant.

Trial Locations

Locations (2)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States