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

Study Overview
=================
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).

Official Title
-----------------
A Randomized Trial of Roadmap 2.0

Conditions
-----------------
Hematologic Diseases

Intervention / Treatment
-----------------
* Other: Wearable activity sensor
* Behavioral: Roadmap 2.0 information system
* Other: Survey administration
* Behavioral: Roadmap 2.0 information system with Positive Activities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria The caregiver must have an eligible patient (see below) The caregiver must be of age ≥18 years. The caregiver should be comfortable in reading and speaking English and signing informed consents. The caregiver should provide at least 50% of care needs. An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs). An eligible patient is age ≥5 years. An eligible patient is scheduled to undergo HCT. An eligible patient is able to sign informed consent/assent forms. Patients and caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved and also in accordance to institutional guidelines. A patient is able to undergo HCT at the U-M only if a designated family caregiver (e.g., parents, adult children, spouses, family members, neighbors, friends) accepts the roles, in accordance to the Clinical Practice Guidelines of the U-M BMT Program. The caregiver and patient must have his/her own smartphone to participate. Exclusion Criteria - Patient does not meet eligibility criteria to undergo HCT at the U-M BMT Program or Oregon Health & Sciences University.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active comparator arm: Adult caregivers (n=166) with adult patients >/= 18 years of age (n=83) and pediatric patient <18 years of age (n=83) Experimental arm: Adult caregivers (n=166) with adult patients >/= 18 years of age (n=83) and pediatric patient <18 years of age (n=83)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roadmap 2.0<br>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 | Other: Wearable activity sensor<br>* Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.<br>* Other names: Fitbit Charge 3;Behavioral: Roadmap 2.0 information system<br>* Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets<br>Other: Survey administration<br>* Caregivers and patients will be asked to respond to survey questions at 3 timepoints.<br>* Other names: PROMIS®;|
| Experimental: Roadmap 2.0 with Positive Activities<br>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 | Other: Wearable activity sensor<br>* Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.<br>* Other names: Fitbit Charge 3;Other: Survey administration<br>* Caregivers and patients will be asked to respond to survey questions at 3 timepoints.<br>* Other names: PROMIS®;Behavioral: Roadmap 2.0 information system with Positive Activities<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale. | 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. | At day 120 post-transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematopoietic Cell Transplantation, Mobile Health Technology