Trial Outcomes & Findings for Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation (NCT NCT04094844)
NCT ID: NCT04094844
Last Updated: 2026-04-14
Results Overview
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. Scores generally range from 20 to 80, with higher scores indicating better health.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
372 participants
Primary outcome timeframe
At day 120 post-transplant
Results posted on
2026-04-14
Participant Flow
Caregiver- Patient dyads were enrolled and reported as individual participants
Participant milestones
| Measure |
Roadmap 2.0 With Positive Activities - Caregivers
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
Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
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.
|
Roadmap 2.0 - Patients
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).
Wearable activity sensor: 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: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
|
Roadmap 2.0 - Caregivers
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
Wearable activity sensor: Caregivers and patients will have a Fitbit wearable activity sensor to track activity and sleep.
Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
|
Roadmap 2.0 With Positive Activities - 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
Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
95
|
95
|
91
|
|
Overall Study
COMPLETED
|
82
|
84
|
84
|
82
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
11
|
9
|
Reasons for withdrawal
| Measure |
Roadmap 2.0 With Positive Activities - Caregivers
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
Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
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.
|
Roadmap 2.0 - Patients
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).
Wearable activity sensor: 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: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
|
Roadmap 2.0 - Caregivers
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
Wearable activity sensor: Caregivers and patients will have a Fitbit wearable activity sensor to track activity and sleep.
Roadmap 2.0 information system: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
|
Roadmap 2.0 With Positive Activities - 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
Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
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.
|
|---|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
2
|
3
|
|
Overall Study
No longer eligible
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
3
|
0
|
|
Overall Study
Enrolled but never started study
|
1
|
1
|
1
|
1
|
Baseline Characteristics
Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation
Baseline characteristics by cohort
| Measure |
Roadmap 2.0 With Positive Activities - Patients
n=91 Participants
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
Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
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.
|
Roadmap 2.0 With Positive Activities - Caregivers
n=91 Participants
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
Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
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.
|
Total
n=372 Participants
Total of all reporting groups
|
Roadmap 2.0 - Patients
n=95 Participants
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
Wearable activity sensor: 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: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
|
Roadmap 2.0 - Caregivers
n=95 Participants
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
Wearable activity sensor: 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: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
|
|---|---|---|---|---|---|
|
Age, Customized
|
50.5 years
n=386 Participants
|
53.2 years
n=112 Participants
|
51.3 years
n=103 Participants
|
50.0 years
n=193 Participants
|
51.6 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=386 Participants
|
71 Participants
n=112 Participants
|
208 Participants
n=103 Participants
|
41 Participants
n=193 Participants
|
67 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=386 Participants
|
20 Participants
n=112 Participants
|
164 Participants
n=103 Participants
|
54 Participants
n=193 Participants
|
28 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=386 Participants
|
4 Participants
n=112 Participants
|
17 Participants
n=103 Participants
|
6 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=386 Participants
|
87 Participants
n=112 Participants
|
355 Participants
n=103 Participants
|
89 Participants
n=193 Participants
|
94 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
7 Participants
n=103 Participants
|
3 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=386 Participants
|
9 Participants
n=112 Participants
|
43 Participants
n=103 Participants
|
12 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=386 Participants
|
76 Participants
n=112 Participants
|
310 Participants
n=103 Participants
|
78 Participants
n=193 Participants
|
80 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
5 Participants
n=103 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
5 Participants
n=103 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=386 Participants
|
91 participants
n=112 Participants
|
372 participants
n=103 Participants
|
95 participants
n=193 Participants
|
95 participants
n=193 Participants
|
PRIMARY outcome
Timeframe: At day 120 post-transplantPopulation: Caregivers only
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. Scores generally range from 20 to 80, with higher scores indicating better health.
Outcome measures
| Measure |
Roadmap 2.0 - Caregivers
n=81 Participants
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
Wearable activity sensor: 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: Caregivers and patients download the Roadmap 2.0 app on their mobile phones or tablets
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
|
Roadmap 2.0 With Positive Activities - Caregivers
n=86 Participants
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
Wearable activity sensor: Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
Survey administration: Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
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.
|
|---|---|---|
|
Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale.
|
48.18 score on a scale
Standard Deviation 11.05
|
48.16 score on a scale
Standard Deviation 8.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At day 120 post-transplantMean 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.
Outcome measures
Outcome data not reported
Adverse Events
Roadmap 2.0 - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Roadmap 2.0 - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Roadmap 2.0 With Positive Activities - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Roadmap 2.0 With Positive Activities - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place