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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2024-08-11

Brief Summary

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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).

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Detailed Description

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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

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Hematologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* 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)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Roadmap 2.0

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

Group Type ACTIVE_COMPARATOR

Wearable activity sensor

Intervention Type OTHER

Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.

Roadmap 2.0 information system

Intervention Type BEHAVIORAL

Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets

Survey administration

Intervention Type OTHER

Caregivers and patients will be asked to respond to survey questions at 3 timepoints.

Roadmap 2.0 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

Group Type EXPERIMENTAL

Wearable activity sensor

Intervention Type OTHER

Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.

Survey administration

Intervention Type OTHER

Caregivers and patients will be asked to respond to survey questions at 3 timepoints.

Roadmap 2.0 information system with Positive Activities

Intervention Type BEHAVIORAL

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.

Interventions

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Wearable activity sensor

Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.

Intervention Type OTHER

Roadmap 2.0 information system

Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets

Intervention Type BEHAVIORAL

Survey administration

Caregivers and patients will be asked to respond to survey questions at 3 timepoints.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Fitbit Charge 3 PROMIS®

Eligibility Criteria

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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.