A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02409121 |
Recruitment Status :
Completed
First Posted : April 6, 2015
Last Update Posted : July 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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Leukemia Lymphoma Brain Tumor | Behavioral: Education information system | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | December 9, 2018 |
Actual Study Completion Date : | December 9, 2018 |
Arm | Intervention/treatment |
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Experimental: Open label
All participants will receive a tablet educational intervention (health IT platform) during the patient inpatient hospitalization for autologous or allogeneic transplant
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Behavioral: Education information system
Participants will receive a mobile tablet as an educational intervention during the patient's inpatient hospitalization |
- Number of subjects who participate in the health information technology educational intervention [ Time Frame: 100 days ]feasibility of recruitment and retention

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participants will be recruited by BMT RN Coordinators and physicians prior to patient admission to the Pediatric BMT Unit. Caregiver (age 18 years or older) of any patient eligible to undergo autologous or allogeneic BMT and any patient (age 10 years or older) eligible to undergo autologous or allogeneic BMT will be recruited during the "Pre-Transplant Work-up" stage in the outpatient setting.
- CAREGIVER PARTICIPANTS: Caregiver (age 18 years or older) of a patient who will be hospitalized to undergo first-time autologous (self) or allogeneic (alternative donor) BMT in the University of Michigan Mott Children's Hospital Pediatric BMT Unit. The age range of patients typically transplanted in the Pediatric BMT unit is 0-25 years. Caregivers with children (patients) who are younger than 10 years of age may be eligible to participate even though their children are too young to assent or participate themselves.
- PATIENT PARTICIPANTS: Patient (age 10 years or older) who will be hospitalized to undergo first-time autologous or allogeneic BMT will be given the opportunity to assent/consent and participate in the study. With his/her permission, the patient will also be provided with their own iPad® BMT Roadmap information system to use. Qualitative interviews will be conducted in patients (age 10 years or older) with their assent/consent. However, patients (age 10-17.9 years) will not be asked to complete surveys, because they have not been validated in this age group. Patients (18 years or older) will be asked to complete surveys. The upper age limit is typically 25 years on the Pediatric BMT Unit. This limit will be determined by only those patients undergoing transplant in the Pediatric BMT Unit.
- Ability to speak and read proficiently in English (the study's instruments have not been translated and validated in languages other than English)
- Willing and able to provide informed consent
- Willing to comply with study procedures and reporting requirements.
Exclusion Criteria:
- Not willing and able to provide informed consent.
- Not willing to comply with study procedures and reporting requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409121
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Responsible Party: | University of Michigan Rogel Cancer Center |
ClinicalTrials.gov Identifier: | NCT02409121 |
Other Study ID Numbers: |
UMCC 2015.050 HUM00100126 ( Other Identifier: University of Michigan ) |
First Posted: | April 6, 2015 Key Record Dates |
Last Update Posted: | July 29, 2019 |
Last Verified: | July 2019 |
hematopoietic cell transplantation caregivers health information technology patient-centered care |
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