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

Hematologic Diseases Clinical Trial

Official title:

A Randomized Trial of Roadmap 2.0

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094844
• Other study ID #: UMCC 2019.106
• Secondary ID: HUM00165192HUM00
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Sung Won Choi, MD, MS
• Phone: 734-615-5707
• Email: sungchoi[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 664
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver health-related quality of life (HRQOL) assessed by PROMIS Profile 29+2 (exploratory)	Mean Profile 29+2 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. This is an exploratory measure.	At day 120 post-transplant
Primary	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