Post-HSCT Medication Adherence mHealth App

February 7, 2023 updated by: Micah Skeens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary caregivers and health care providers of children discharged during the acute phase (first 100 days) post-hematopoietic stem cell transplant (HSCT).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Caregivers
Primary caregivers of children receiving Tacrolimus or cyclosporine immunosuppression for an allogeneic transplant will be introduced to the mHealth adherence app and allowed the opportunity to interact with the app alongside research staff. Following this session primary caregivers are asked to use the app at home until Day 100 or weaning of immunosuppressant, whichever is first.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: Baseline to day 100
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Micah Skeens

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Micah Skeens, PhD APRN CPNP, Abigail Wexner Research Institute at Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2021

Primary Completion (ACTUAL)

January 31, 2023

Study Completion (ACTUAL)

January 31, 2023

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (ACTUAL)

July 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00000910
  • K99NR019115-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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