BMT4me: Post-HSCT Medication Adherence mHealth App

NCT05515497 | Completed

• 2 other identifiers: STUDY000024784R00NR019115-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a mixed methods, prospective longitudinal pilot RCT to evaluate the 1) acceptability of a newly developed mHealth app (BMT4me), 2) the feasibility of enrolling and retaining caregivers of children in the acute phase post-HSCT, and 3) the potential efficacy of an mHealth app on adherence to immunosuppressants in post-HSCT children discharged during the acute phase.

Conditions

Stem Cell Transplant; Adherence, Medication; Digital Health

Keywords

Adherence; mHealth; Stem Cell transplant; Immunosuppression; Digital Health; Pediatrics

Outcome Measures

Primary Outcomes (8)

• Momentary Event Monitoring System (MEMS) Caps

  MEMS Caps collect daily data via a micro-electronic circuit that registers the opening and closing of the threaded pill bottle. Each opening and closing is assumed to reflect an administered and consumed medication dose. This data will be collected either at weekly or monthly from participants at their visits in the BMT clinic as a direct measure of adherence. Electronic monitors contain micro-electronic circuits that date and time-stamp each time the container is opened to remove a dose of medication. Data from the electronic monitors will be downloaded using cloud or computer-based software, at each study visit.53,54 An adherence percentage was calculated by dividing the number of doses taken by the number of doses prescribed for each day. All of the electronic monitors have been independently tested for accuracy.55

  Baseline to day 100

• Medication Adherence Measure (MAM)

  The MAM is semi-structured interview specific to pediatrics, conducted with the parent, to obtain an individual score in each module. The score is represented in percentages of the number of required doses. A total summary score can be calculated across all medications, as well as separately. This allows for quantification of the degree of adherence on a continuum. MAM has demonstrated adequate convergent validity with MEMs caps (r =-.40, p \< .05).

  Baseline to day 100

• System Usability Scale

  The SUS is a 10-item questionnaire routinely used to evaluate the functionality and acceptability of mHealth apps. Items are rated on a 5 point scale and scores range from 0 to 100. Reliability (0.91) and validity (.81 correlation with 7- point scale of "user friendliness") have been well established. A score of \> 68% is considered above average.

  Exit (Day 100)

• Posttransplant Perception Survey

  The posttransplant perception survey is a self-report clinical assessment tool adapted from the kidney transplant population for this trail. The tool contains 4 items asking participants to report on their views about their child's health and perceptions post-transplant. Items are rated on a 5 point Likert scale.

  Baseline (Week 0)

• Barrier Assessment Tool

  The Barrier Assessment Tool (BAT) is a self-report clinical assessment tool. The tool contains 14 commonly endorsed barriers with a checkbox next to each item. Domains include logistical issues (e.g., forgetting, inconvenience), ingestion difficulties (e.g., swallowing, taste), efficacy (e.g., feel I don't need it), financial difficulties, regimen characteristics (e.g., too many medications, side effects), and patient-specific issues (e.g., refusal by child, embarrassment). A sum total of the number of barriers is calculated, as well as concordance between caregiver and patient report. In the feasibility study, the average concordance between caregiver and patient report of each barrier (n=48) was 0.299.53 The total barrier score will be used. A sum total of 0 to 14 could be calculated, with higher scores indicating more barriers.

  Baseline (Week 0)

• Caregiver Satisfaction

  Satisfaction will be assessed via semi-structured interviews and an electronic version of the Caregiver Satisfaction Questionnaire with caregivers. Caregivers will be asked for feedback regarding participation in the intervention, benefit, burden, barriers, suggested modifications, and overall satisfaction. Suggested modifications to the app and advice to the healthcare team will also be solicited. Due to the qualitative nature of the interview, caregiver responses cannot be scored but will be coded for themes. Questions on the Caregiver Satisfaction Questionnaire are scored on a 1 to 4 Likert scale with higher total scores indicating higher caregiver satisfaction.

  Exit (Day 100)

• Pediatric Quality of Life Inventory (PedsQL) version 4.0

  Parents will complete the Pediatric Quality of Life Inventory (PedsQL) every three weeks (at week 3, week 6, and week 9). The frequency of 23 problems in 4 domains (i.e., physical, emotional, social, school) are rated on a 3 or 5-point scale. Versions are based on child age: (a) 5-7, (b) 8-12 and, (c) 13-18 years old.

  Week 3, Week 6, and Week 9

• Medy Remote Patient Management (RPM) medication box by Vaica

  Medy RPM collects daily data via an NFC reader. Each opening and closing is assumed to reflect an administered and consumed medication dose. This data will be collected monthly from participants as a direct measure of adherence. Electronic monitors contain micro-electronic circuits that date and time-stamp each time the container is opened to remove a dose of medication. Data from the electronic monitors will be downloaded using cloud or computer-based software, at each study visit. An adherence percentage was calculated by dividing the number of doses taken by the number of doses prescribed for each day. All of the electronic monitors have been independently tested for accuracy.

  Baseline to day 100

Secondary Outcomes (5)

• Demographic Data Form

  Baseline (Week 0)

• Medication Possession Ratio (MPR)

  Monthly until day 100

• Medication Level Variability Index (MLVI)

  Weekly until day 100

• Graft vs. Host Disease (GVHD)

  Weekly until day 100

• Readmissions

  Weekly until day 100

Study Arms (2)

BMT4me 2.0 Intervention Group

EXPERIMENTAL

The intervention group will be receiving the BMT4me 2.0 app at discharge as the primary intervention.

Device: BMT4me 2.0 app

BMT4me 2.0 Control Group

NO INTERVENTION

The control group will be receiving usual care at discharge. These participants will not be receiving the BMT4me 2.0 app.

Interventions

BMT4me 2.0 app DEVICE

The BMT4me app was designed by AWRI RISI developers and has been through multiple phases of stakeholder testing. The app is a virtual assistant for caregivers, allowing for medication record keeping, medication and refill reminders, symptom tracking, and a word and picture journal. All data is secured on the individuals password protected phone.

BMT4me 2.0 Intervention Group

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children of caregivers must be a) 0 to 21 years of age; b) receiving immunosuppression for an allogeneic transplant or anti-infective for an autologous transplant; c) discharged prior to Day 100 or completion of immunosuppression taper, and d) residing with the primary caregiver that enrolls on the study.
• Primary caregivers must be: d) English-speaking; and e) have an iOS or Android capable cellular device.

You may not qualify if:

• Adults unable to consent

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

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: November 29, 2022
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)