Adherence, Medication Clinical Trial
— Bmt4me 2Official title:
BMT4me: Improving Adherence Through mHealth for Pediatric Stem Cell Transplant Patients (BMT4me 2.0)
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 29, 2025 |
Est. primary completion date | November 29, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 21 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Adults unable to consent |
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Micah Skeens | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | Demographic Data Form | The demographic data form is a questionnaire used to evaluate basic background characteristics including parent and child age, sex, race, ethnicity, education level, and family income. | Baseline (Week 0) | |
Secondary | Medication Possession Ratio (MPR) | MPR is a standard adherence measure that uses pharmacy refill records to calculate adherence using the sum of the days' supply obtained between the first pharmacy fill and the last fill divided by the total number of days. Higher scores indicate better adherence. The number of refills increases accuracy of the adherence estimate. | Monthly until day 100 | |
Secondary | Medication Level Variability Index (MLVI) | The MLVI is the calculation of the standard deviation of serum assays of immunosuppressants that has shown to correlate with adherence and clinical outcomes in the solid organ transplant population.54 Immunosuppressant serum assays are collected weekly during the acute phase. A calculation of the degree of variation among levels will be formulated. | Weekly until day 100 | |
Secondary | Graft vs. Host Disease (GVHD) | GVHD will be assessed on the international standard acute GVHD grading and staging scale. Provider grading will be per organ system on a 1-4 scale, with an overall score given weekly. | Weekly until day 100 | |
Secondary | Readmissions | Readmission rates will be determined by the number of admissions requiring greater than a 24-hour stay within the first 100 days after discharge. Reason for readmission will be recorded and based on the EMR discharge diagnosis. In addition, a sub-analysis of readmissions within the first 30 days after initial discharge post-HSCT will be completed. | Weekly until day 100 |
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