Spanish BMT4me Usability & Acceptability

Bone Marrow Transplant Clinical Trial

Official title:

Spanish BMT4me Usability & Acceptability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361173
• Other study ID #: STUDY00004127
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

Inclusion Criteria:

Eligible caregivers must have children who:

1. Are 0-17 years old

2. Underwent HCT

3. Are planned for discharge prior to day 100 post-transplant

Primary caregivers must:

1. Be Spanish speaking

2. Be =18 years old

3. Have a smartphone (iOS or Android) capable of downloading apps Exclusion Criteria: (a) Children or caregivers with pre-existing neurodevelopmental disorder/disability or a pervasive developmental disorder will be excluded from this study.

Related Conditions & MeSH terms

• Bone Marrow Transplant

Intervention

Other:
• BMT4me
Caregivers will pilot test a Spanish version of the BMT4me app at a single time point.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess app usability using the System Usability Scale (SUS)	Data collected using the System Usability Scale (SUS) will provide insight to the usability of the Spanish BMT4Me app in its current form. he SUS is a 10-item questionnaire routinely used to evaluate the functionality and acceptability of mHealth apps. The SUS is scored on a scale, giving a score from from 0 to 100 where 100 is considered the highest rating of usability. A score of > 68 is considered above average.	6/1/24 - 5/1/26