NCT06361173

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
Last Updated

November 4, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

April 2, 2024

Last Update Submit

November 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Spanish-speaking caregivers

Spanish-speaking caregivers recruited from Nationwide Children's Hospital and Columbia University Irving Medical Center to pilot test a Spanish a transcreated version of the BMT4me app

Other: BMT4me

Interventions

BMT4meOTHER

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

Spanish-speaking caregivers

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study will recruit 30 self-identified Spanish speaking primary caregivers of children post-HCT at two institutions.

You may qualify if:

  • Eligible caregivers must have children who:
  • Are 0-17 years old
  • Underwent HCT
  • Are planned for discharge prior to day 100 post-transplant
  • Primary caregivers must:
  • Be Spanish speaking
  • Be ≥18 years old
  • Have a smartphone (iOS or Android) capable of downloading apps

You may not qualify if:

  • (a) Children or caregivers with pre-existing neurodevelopmental disorder/disability or a pervasive developmental disorder will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10027, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 11, 2024

Study Start

October 9, 2024

Primary Completion

September 24, 2025

Study Completion

September 24, 2025

Last Updated

November 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Aggregate data will be shared upon request.

Locations