Post-HSCT Medication Adherence mHealth App

NCT04976933 | Completed

• 2 other identifiers: STUDY00000910K99NR019115-01A1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation

Keywords

adherence, mHealth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

mHealth adherence app BEHAVIORAL

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.

Primary Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• English-speaking
• \>18 years of age

You may not qualify if:

• Caregivers with developmental delays or conditions that make processing and responding to verbal questions challenging/frustrating either online or in a group forum

Sponsors & Collaborators

• Micah Skeens: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Skeens M, Sezgin E, Stevens J, Landier W, Pai A, Gerhardt C. An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study. JMIR Res Protoc. 2022 Jul 21;11(7):e39098. doi: 10.2196/39098.

  PMID: 35862184 DERIVED

Study Officials

• Micah Skeens, PhD APRN CPNP

  Abigail Wexner Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Scientist/Principal Investigator

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: September 15, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)