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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Hematologic Diseases

Treatments: Behavioral: Roadmap 2.0 information system with Positive Activities; Other: Wearable activity sensor; Other: Survey administration; Behavioral: Roadmap 2.0 information system

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04094844

R01HL146354 (U.S. NIH Grant/Contract)

HUM00186436 (Other Identifier)

UMCC 2019.106

HUM00165192 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 372 patients

Sex: All

Ages: 5 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 2 patient groups

Roadmap 2.0

Active Comparator group

Description:

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

Treatment:

Behavioral: Roadmap 2.0 information system

Other: Survey administration

Other: Wearable activity sensor

Roadmap 2.0 with Positive Activities

Experimental group

Description:

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

Treatment:

Other: Survey administration

Other: Wearable activity sensor

Behavioral: Roadmap 2.0 information system with Positive Activities