Post-HSCT Medication Adherence mHealth App

• Sponsor: Micah Skeens (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04976933
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplantation	Behavioral: mHealth adherence app

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Design and Feasibility of mHealth App for Pediatric Medication Adherence Post-discharge for Hematopoietic Stem Cell Transplant
• Actual Study Start Date: Sep 15, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. System Usability Scale (SUS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Micah Skeens
• National Institute of Nursing Research (NINR)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Micah Skeens, Nurse Scientist/Principal Investigator, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT04976933
• Other Study ID Numbers: STUDY00000910; K99NR019115-01A1
• First Posted: Jul 26, 2021
• Last Update Posted: Oct 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Micah Skeens, Nurse Scientist/Principal Investigator, Nationwide Children's Hospital: adherence, mHealth

Study Results

No Results Posted as of Oct 19, 2021