← Back to Search

Behavioural Intervention

Medication Adherence App for Bone Marrow Transplant Care (Bmt4me 2 Trial)

N/A

Recruiting

Research Sponsored by Micah Skeens

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children must be receiving immunosuppression for an allogeneic transplant

Primary caregivers must be English-speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 3, week 6, and week 9

Awards & highlights

Bmt4me 2 Trial Summary

This trial will study a new app designed to help caretakers of children who have recently undergone a hematopoietic stem cell transplant (HSCT) keep track of their immunosuppressant medication. The study will assess the feasibility of enrolling and retaining caregivers in the study, as well as the potential efficacy of the app in helping to improve adherence to immunosuppressant medication.

Who is the study for?

This trial is for primary caregivers who speak English and have an iOS or Android device. Their children must be aged 2-12, receiving immunosuppression post-allogeneic bone marrow transplant, and discharged before Day 100 of immunosuppression tapering. Adults unable to consent and pregnant women cannot participate.Check my eligibility

What is being tested?

The BMT4me study tests a mobile health app designed to help caregivers manage their child's medication after a bone marrow transplant. It looks at how well the app is received, its ability to keep participants engaged over time, and if it improves adherence to taking prescribed immunosuppressants.See study design

What are the potential side effects?

Since this trial involves using a mobile health application rather than medication or medical procedures, there are no direct physical side effects associated with traditional clinical trials. However, technical issues or user experience problems may occur.

Bmt4me 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is on immunosuppressants for a transplant from a donor.

Select...

My primary caregiver speaks English.

Bmt4me 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 3, week 6, and week 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 3, week 6, and week 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3, week 6, and week 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Barrier Assessment Tool

Caregiver Satisfaction

Medication Adherence Measure (MAM)

+5 more

Secondary outcome measures

Demographic Data Form

Graft vs. Host Disease (GVHD)

Medication Level Variability Index (MLVI)

+2 more

Bmt4me 2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BMT4me 2.0 Intervention GroupExperimental Treatment1 Intervention

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

Group II: BMT4me 2.0 Control GroupActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Micah SkeensLead Sponsor

1 Previous Clinical Trials

15 Total Patients Enrolled

National Institute of Nursing Research (NINR)NIH

579 Previous Clinical Trials

10,376,332 Total Patients Enrolled

Media Library

BMT4me 2.0 app (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05515497 — N/A

Bone Marrow Transplant Research Study Groups: BMT4me 2.0 Intervention Group, BMT4me 2.0 Control Group

Bone Marrow Transplant Clinical Trial 2023: BMT4me 2.0 app Highlights & Side Effects. Trial Name: NCT05515497 — N/A

BMT4me 2.0 app (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515497 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in the study thus far?

"Affirmative. The information posted on clinicaltrials.gov attests to the current recruitment status of this medical trial, which was first made available as early as September 6th 2022 and most recently modified on September 21st 2022. For now, 40 patients are needed from a single site in order for it to commence."

Answered by AI

What is the main purpose of this experiment?

"The chief outcome of this investigation, evaluated from Baseline to day 100, is the Momentary Event Monitoring System (MEMS) Caps. Secondary outcomes include Readmissions determined by 24-hour post-discharge admissions within a hundred days and Medication Possession Ratio (MPR), an adherence measure that uses pharmacy refill records. Moreover, there's also Demographic Data Form which inquiries parent/child age, sex, ethnicity education level and family income."

Answered by AI

Are there any unfilled positions in this medical experiment?

"Affirmative. Clinical trials website data reveals that this medical research, initially posted on September 6th 2022, is currently recruiting participants. Approximately 40 patients must be enlisted from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BMT4me: Post-HSCT Medication Adherence mHealth App

Micah Skeens 2022. "BMT4me: Post-HSCT Medication Adherence mHealth App". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05515497.