Spanish BMT4me Usability & Acceptability

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Marrow Transplant
• Intervention / Treatment: Other: BMT4me

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University Irving Medical Center
      • Contact: Melissa Beauchemin; Email: mmp2123@cumc.columbia.edu
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Nationwide Children's Hospital
      • Contact: Bianca Franklin, BS
      • Principal Investigator: Micah Skeens, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Caregivers will pilot test a Spanish version of the BMT4me app at a single time point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Collaborators: Columbia University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate data will be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No