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NCT04976933 Clinical Trial

Post-HSCT Medication Adherence mHealth App

Stem Cell Transplantation Clinical Trial

Official title:
Design and Feasibility of mHealth App for Pediatric Medication Adherence Post-discharge for Hematopoietic Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04976933
Other study ID # STUDY00000910
Secondary ID K99NR019115-01A1
Status Completed
Phase
First received
Last updated
Start date September 15, 2021
Est. completion date January 31, 2023

Study information
Verified date February 2023
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Through a mixed methods, quasi-experimental design, the study will first focus on developing a mobile health (mHealth) adherence application and evaluating usability and acceptability of the app among caregivers of children in the acute phase post-HSCT. The purpose of this project is to explore the feasibility and acceptability of a mHealth application through user testing and thematic content analysis.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - English-speaking - >18 years of age Exclusion Criteria: - Caregivers with developmental delays or conditions that make processing and responding to verbal questions challenging/frustrating either online or in a group forum

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• mHealth adherence app
The mHealth app is designed to remind caregivers to give medication in the outpatient setting, track adherence, and capture real time barriers to adherence if medication is missed.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (2)
Lead Sponsor Collaborator
Micah Skeens National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary System Usability Scale (SUS) The SUS is a 10-item questionnaire used to evaluate the functionality and acceptability of mHealth apps. Items are rated on a 5 point scale and final scores on the measure range from 0 to 100. Higher scores represent better functionality and acceptability. Scores of > 68 are considered above average. Baseline to day 100
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