Stem Cell TransplantBmt4me 2NCT05515497
BMT4me: Post-HSCT Medication Adherence mHealth App
A study testing BMT4me 2.0 app in people with Stem Cell Transplant and Adherence, Medication, run by Micah Skeens at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Stem Cell Transplant, Adherence, Medication, Digital Health
- What is being tested?
- BMT4me 2.0 app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 2 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official 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.
Read the detailed description
In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in healthcare costs annually Adherence rates have been reported as low as 0% in pediatric patients. Reasons for non-adherence are multifactorial. The most important determinants of non-adherence are consistently documented as complexity and duration of treatment regimens, as well as forgetfulness. Thus, children undergoing difficult hematopoietic stem cell transplants (HSCT) that require medication indefinitely are at high risk for medication non-adherence.
Only 4 published studies exist regarding adherence in pediatric HSCT. None address adherence to immunosuppressant medication, nor are they RCTs. Second, the complexity of most interventions for adherence is counter to the geographic, resource, and time constraints families of chronically ill children face. Adherence interventions based on conventional behavior theory have been cumbersome for families already stressed due to chronic illness. BE design is a significant paradigm shift to a simpler, less onerous approach that can engage those patients and families that would otherwise forego complicated adherence interventions. Although mHealth adherence apps are a widely available, simple, and innovative approach to addressing these problems, a third gap relates to poor usability. For example, a recent review of pediatric adherence apps found that none identified individual barriers to adherence, and nearly all were designed for adults. Thus, there is an urgent need to develop and evaluate innovative, accessible, and evidence-based approached to adherence among children receiving HSCT to prevent morbidity and mortality from GVHD.
The impact of non-adherence on clinical outcomes is largely unknown in pediatric HSCT. poor adherence is generally associated with adverse outcomes, including complications, hospital admissions, and even death. The societal burden of cancer care and HSCT is substantial and likely to increase based on the growing number of transplants each year. Clinicians and researchers have focused on GVHD prevention to minimize unnecessary treatment-related deaths. Acute GVHD develops in the first 100 days post-transplant. Children that develop acute GVHD have a 30% to 50% chance of survival. Morbidity and mortality due to GVHD can be decreased through prophylactic use of immunosuppressants. Although these medications are costly and produce unpleasant side effects, adherence is critical to decrease complications, reduce readmissions, and ultimately increase quality of life and survival.
Adherence is complex, but ultimately, the final common pathway to adherence is human behavior. In pediatrics, adherence is largely dependent on parents. As the primary caregivers, they are responsible for ensuring children receive the prescribed therapy correctly. In a high-risk HSCT population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. Alternatively, behavioral economics (BE) theory suggests that small "nudges" can produce and sustain behavior change. A BE approach is a significant paradigm shift and assumes decision-making can be influenced through low-intensity interventions to lead patients to optimal choices. Improved adherence to medication and exercise programs using BE designed interventions in adults have been positive. Within pediatrics, BE has been successful in reducing childhood obesity, increasing vaccination rates, and improving adherence rates to infant HIV medications.
- Conditions
- Stem Cell Transplant, Adherence, Medication, Digital Health
- Being tested
- BMT4me 2.0 app
- Keywords
- Adherence, mHealth, Stem Cell transplant, Immunosuppression, Digital Health, Pediatrics
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT4me 2.0 appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BMT4me 2.0 Intervention Group | Experimental | The intervention group will be receiving the BMT4me 2.0 app at discharge as the primary intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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. A higher score indicates better usability. Reliability and validity have been well established. A score of > 68% is considered above average.
Measured: 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 trial. The tool contains 7 questions asking participants to report on their views about their child's health and perceptions post-transplant. Questions are rated on a 5-point Likert scale. The first three questions related to worry about child's health and are considered the "Worry" subscale which ranges from 3 to 15, with higher scores indicating more worry. The second four questions relate to the understanding of child's health and are considered the "Understanding" subscale. Scores range from 4 to 20, where higher scores indicate less understanding.
Measured: Baseline (Week 0) to 100 Days Post Transplant
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.
Measured: Baseline (Week 0) to 100 Days Post Transplant
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. Nine questions are included on the Caregiver Satisfaction Questionnaire and responses are on a 1 to 4 Likert scale. A total sum score ranges from 9 to 36, with higher scores indicating more satisfaction.
Measured: Exit (Day 100)
Pediatric Quality of Life Inventory (PedsQL) Version 4.0
Caregivers completed the Pediatric Quality of Life Inventory (PedsQL) every three weeks (at week 3, week 6, and week 9). The PedsQL has 4 domains related to physical, emotional, social, and school functioning totaling 23 items. Items are rated on a 3 or 5-point Likert scale. All items (23) are summed to a total PedsQL score. Total scores range from 0 - 100, with higher scores indicating higher quality of life. Versions are based on child age: (a) 5-7, (b) 8-12 and, (c) 13-18 years old.
Measured: 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.
Measured: Baseline to day 100
Wisepill
Wisepill is a pillbox that collects data on medication usage through the internet. The Wisepill model utilized was evriMED1000. This data was collected as a direct measure of adherence. The evriMED1000 pillbox recorded when the lid was opened and closed and uploaded data in real time into a cloud-based server, where data was retrieved after study exit.
Measured: Baseline to day 100
Secondary outcomes (5)
Medication Level Variability Index (MLVI)
Medication Level Variability Index (MLVI) measures the variation of tacrolimus levels in the blood of a patient over time. Higher variability has been associated with increased risk of poor outcomes following solid organ transplant, with limited findings suggesting a similar trend in HCT. MLVI is calculated using the standard deviation of three or more medication levels. The range of scores is not consistent, but MLVI typically falls between 0-10, with higher scores indicating higher variability (and therefore higher risk of complications). There are clinically significant cutoff scores for solid organ transplant populations; an MLVI of 3 or higher is generally considered to be a high risk. Both continuous and dichotomous scores were used in this analysis.
Measured: Weekly until day 100
Number of Participants With 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.
Measured: Weekly until day 100
Number of Participants With 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.
Measured: Weekly until day 100
Caregiver Education Level
Caregiver reported education level
Measured: Baseline (Week 0)
Annual Household Income
Caregiver reported annual household income
Measured: Baseline (Week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start29 Nov 2022
- Primary completion2 Jan 2026
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stem Cell TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Micah Skeens
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Micah Skeens, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515497
- Sponsor's protocol ID
- STUDY00002478
- Other IDs
- 4R00NR019115-03
- Acronym
- Bmt4me 2
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2022
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMT4me: Improving Adherence Through mHealth for Pediatric Stem Cell Transplant Patients (BMT4me 2.0)
- ClinicalTrials.gov ID
- NCT05515497
- Acronym / sponsor ID
- Bmt4me 2 / STUDY00002478
- Conditions
- Stem Cell Transplant, Adherence, Medication, Digital Health
- Keywords
- Adherence, mHealth, Stem Cell transplant, Immunosuppression, Digital Health, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Micah SkeensUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in healthcare costs annually Adherence rates have been reported as low as 0% in pediatric patients. Reasons for non-adherence are multifactorial. The most important determinants of non-adherence are consistently documented as complexity and duration of treatment regimens, as well as forgetfulness. Thus, children undergoing difficult hematopoietic stem cell transplants (HSCT) that require medication indefinitely are at high risk for medication non-adherence.
Only 4 published studies exist regarding adherence in pediatric HSCT. None address adherence to immunosuppressant medication, nor are they RCTs. Second, the complexity of most interventions for adherence is counter to the geographic, resource, and time constraints families of chronically ill children face. Adherence interventions based on conventional behavior theory have been cumbersome for families already stressed due to chronic illness. BE design is a significant paradigm shift to a simpler, less onerous approach that can engage those patients and families that would otherwise forego complicated adherence interventions. Although mHealth adherence apps are a widely available, simple, and innovative approach to addressing these problems, a third gap relates to poor usability. For example, a recent review of pediatric adherence apps found that none identified individual barriers to adherence, and nearly all were designed for adults. Thus, there is an urgent need to develop and evaluate innovative, accessible, and evidence-based approached to adherence among children receiving HSCT to prevent morbidity and mortality from GVHD.
The impact of non-adherence on clinical outcomes is largely unknown in pediatric HSCT. poor adherence is generally associated with adverse outcomes, including complications, hospital admissions, and even death. The societal burden of cancer care and HSCT is substantial and likely to increase based on the growing number of transplants each year. Clinicians and researchers have focused on GVHD prevention to minimize unnecessary treatment-related deaths. Acute GVHD develops in the first 100 days post-transplant. Children that develop acute GVHD have a 30% to 50% chance of survival. Morbidity and mortality due to GVHD can be decreased through prophylactic use of immunosuppressants. Although these medications are costly and produce unpleasant side effects, adherence is critical to decrease complications, reduce readmissions, and ultimately increase quality of life and survival.
Adherence is complex, but ultimately, the final common pathway to adherence is human behavior. In pediatrics, adherence is largely dependent on parents. As the primary caregivers, they are responsible for ensuring children receive the prescribed therapy correctly. In a high-risk HSCT population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. Alternatively, behavioral economics (BE) theory suggests that small "nudges" can produce and sustain behavior change. A BE approach is a significant paradigm shift and assumes decision-making can be influenced through low-intensity interventions to lead patients to optimal choices. Improved adherence to medication and exercise programs using BE designed interventions in adults have been positive. Within pediatrics, BE has been successful in reducing childhood obesity, increasing vaccination rates, and improving adherence rates to infant HIV medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMT4me 2.0 Intervention Group | Experimental | Device: BMT4me 2.0 appThe intervention group will be receiving the BMT4me 2.0 app at discharge as the primary intervention. |
| 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. |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Adults unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMT4me 2.0 appThe 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. | Device | BMT4me 2.0 Intervention Group |
Primary outcome
Momentary Event Monitoring System (MEMS) Caps
Time frame: Baseline to day 100
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
Medication Adherence Measure (MAM)
Time frame: Baseline to day 100
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.
System Usability Scale
Time frame: Exit (Day 100)
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. A higher score indicates better usability. Reliability and validity have been well established. A score of > 68% is considered above average.
Posttransplant Perception Survey
Time frame: Baseline (Week 0) to 100 Days Post Transplant
The posttransplant perception survey is a self-report clinical assessment tool adapted from the kidney transplant population for this trial. The tool contains 7 questions asking participants to report on their views about their child's health and perceptions post-transplant. Questions are rated on a 5-point Likert scale. The first three questions related to worry about child's health and are considered the "Worry" subscale which ranges from 3 to 15, with higher scores indicating more worry. The second four questions relate to the understanding of child's health and are considered the "Understanding" subscale. Scores range from 4 to 20, where higher scores indicate less understanding.
Barrier Assessment Tool
Time frame: Baseline (Week 0) to 100 Days Post Transplant
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.
Caregiver Satisfaction
Time frame: Exit (Day 100)
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. Nine questions are included on the Caregiver Satisfaction Questionnaire and responses are on a 1 to 4 Likert scale. A total sum score ranges from 9 to 36, with higher scores indicating more satisfaction.
Pediatric Quality of Life Inventory (PedsQL) Version 4.0
Time frame: Week 3, Week 6, and Week 9
Caregivers completed the Pediatric Quality of Life Inventory (PedsQL) every three weeks (at week 3, week 6, and week 9). The PedsQL has 4 domains related to physical, emotional, social, and school functioning totaling 23 items. Items are rated on a 3 or 5-point Likert scale. All items (23) are summed to a total PedsQL score. Total scores range from 0 - 100, with higher scores indicating higher quality of life. Versions are based on child age: (a) 5-7, (b) 8-12 and, (c) 13-18 years old.
Medy Remote Patient Management (RPM) Medication Box by Vaica
Time frame: Baseline to day 100
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.
Wisepill
Time frame: Baseline to day 100
Wisepill is a pillbox that collects data on medication usage through the internet. The Wisepill model utilized was evriMED1000. This data was collected as a direct measure of adherence. The evriMED1000 pillbox recorded when the lid was opened and closed and uploaded data in real time into a cloud-based server, where data was retrieved after study exit.
5 secondary outcomes
Medication Level Variability Index (MLVI)
Time frame: Weekly until day 100
Number of Participants With Graft vs. Host Disease (GVHD)
Time frame: Weekly until day 100
Number of Participants With Readmissions
Time frame: Weekly until day 100
Caregiver Education Level
Time frame: Baseline (Week 0)
Annual Household Income
Time frame: Baseline (Week 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMT4me 2.0 app in people with Stem Cell Transplant and Adherence, Medication, run by Micah Skeens at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Momentary Event Monitoring System (MEMS) Caps (time frame: Baseline to day 100). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.