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

Primary Purpose

Hematologic Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wearable activity sensor

Roadmap 2.0 information system

Survey administration

Roadmap 2.0 information system with Positive Activities

About this trial

This is an interventional supportive care trial for Hematologic Diseases focused on measuring Hematopoietic Cell Transplantation, Mobile Health Technology

Eligibility Criteria

5 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan Rogel Cancer CenterRecruiting
Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Roadmap 2.0

Roadmap 2.0 with Positive Activities

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04094844

First Posted

September 16, 2019

Last Updated

December 20, 2022

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Department of Health and Human Services

1. Study Identification

Unique Protocol Identification Number

NCT04094844

Brief Title

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

Official Title

A Randomized Trial of Roadmap 2.0

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Diseases

Keywords

Hematopoietic Cell Transplantation, Mobile Health Technology

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

664 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Roadmap 2.0

Arm Type

Active Comparator

Arm Description

Arm Title

Roadmap 2.0 with Positive Activities

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Wearable activity sensor

Other Intervention Name(s)

Fitbit Charge 3

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Roadmap 2.0 information system

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Survey administration

Other Intervention Name(s)

PROMIS®

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Roadmap 2.0 information system with Positive Activities

Intervention Description

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.

Primary Outcome Measure Information:

Title

Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale.

Description

Time Frame

At day 120 post-transplant

Other Pre-specified Outcome Measures:

Title

Caregiver health-related quality of life (HRQOL) assessed by PROMIS Profile 29+2 (exploratory)

Description

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.

Time Frame

At day 120 post-transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sung Won Choi, MD, MS

Phone

734-615-5707

sungchoi@med.umich.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Cislo

Phone

313-727-2073

ccislo@med.umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung Won Choi, MD, MS

Organizational Affiliation

University of Michigan Rogel Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Rogel Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung Won Choi, MD, MS

Phone

734-615-5707

sungchoi@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Sung Choi, MD, MS

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amanda Johnson

Phone

503-418-5150

amanda@ohsu.edu

First Name & Middle Initial & Last Name & Degree

Evan B Shereck, M.D., M.Ed

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32945777

Citation

Rozwadowski M, Dittakavi M, Mazzoli A, Hassett AL, Braun T, Barton DL, Carlozzi N, Sen S, Tewari M, Hanauer DA, Choi SW. Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 18;9(9):e19288. doi: 10.2196/19288.

Results Reference

derived

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

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