Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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 |
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.
Other Names:
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.
Other Names:
|
| Experimental: 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 |
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.
Other Names:
Other: Survey administration
Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
Other Names:
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.
|
Outcome Measures
Primary Outcome Measures
- Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale. [At day 120 post-transplant]
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.
Other Outcome Measures
- Caregiver health-related quality of life (HRQOL) assessed by PROMIS Profile 29+2 (exploratory) [At day 120 post-transplant]
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.
Eligibility Criteria
Criteria
Inclusion Criteria
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The caregiver must have an eligible patient (see below)
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The caregiver must be of age ≥18 years.
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The caregiver should be comfortable in reading and speaking English and signing informed consents.
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The caregiver should provide at least 50% of care needs.
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An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs).
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An eligible patient is age ≥5 years.
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An eligible patient is scheduled to undergo HCT.
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An eligible patient is able to sign informed consent/assent forms.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | United States | 48109 |
| 2 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- University of Michigan Rogel Cancer Center
- Department of Health and Human Services
Investigators
- Principal Investigator: Sung Won Choi, MD, MS, University of Michigan Rogel Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UMCC 2019.106
- HUM00165192
- HUM00186436