The MedMemos Study: Promoting Adherence to Medications in Pediatric Bone Marrow Transplant Patients (MedMemos)

July 17, 2026 updated by: Ahna Pai, Nationwide Children's Hospital

MedMemos: An Intervention to Promote Medication Adherence in Pediatric Allogenic Hematopoietic Stem Cell Transplantation

The goal of this clinical trial is to test the MedMemos Intervention with parents and children who have received a bone marrow transplant. The main study questions are:

  • Is the MedMemos intervention acceptable to patients and families?
  • Is the MedMemos intervention feasible for patients, families, and healthcare providers?
  • Does MedMemos help patients and families take their medications better?

Participants will be asked to complete surveys, attend 4 intervention sessions, and use an electronic box or pill bottle to store their medications in.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will assess the acceptability, feasibility, and proof-of-concept for MedMemos, a novel medication adherence promotion intervention developed for caregivers of children who received a pediatric hematopoietic stem cell transplant (PAHCT).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Child had a Pediatric Allogeneic Hematopoietic Cell Transplant (PAHCT)
  • Child is 0-12 years of age
  • At the time of recruitment child is still in the hospital for PAHCT
  • Child's primary caregiver is responsible for administering medical care and is willing to give consent to participate
  • Child is prescribed an oral medication regimen at discharge

Exclusion Criteria:

  • Caregiver does not speak English, Spanish, or Arabic
  • Caregiver is not available to provide written permission for the child's participation
  • EMR or medical team report of the caregiver's cognitive status precludes completion of questionnaires
  • The child's medical status or condition precludes completion of the study questionnaires as determined by the physician or caregiver
  • Caregiver is unwilling to store medication in an electronic monitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MedMemos
This arm will provide participants with the MedMemos Intervention
Behavioral: MedMemos
MedMemos is a 4-session tailored adherence promotion intervention that will provide caregivers with a combination of tailored and standardized medication and adherence education videos and a "Medication Management Kit" that provides tailored strategies to target identified barriers to successful medication management.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention Acceptability
Time Frame: At the end of session 4 (An average of 14 days following the patient's hospital discharge, up to 28 days following discharge)
Intervention acceptability will be demonstrated by caregivers rating MedMemos a mean of ≥ 4 as measured on Acceptability of Intervention Measure, Feasibility of Intervention Measure, and Intervention Appropriateness Measure. Each measure asks participants to rate statements on a scale of "Completely Disagree" to "Completely Agree" Higher scores indicate greater acceptability, feasibility, and appropriateness.
At the end of session 4 (An average of 14 days following the patient's hospital discharge, up to 28 days following discharge)
Intervention Feasibility - Percentage of patients who enroll out of those approached
Time Frame: Enrollment rate will be continually monitored throughout enrollment and final enrollment percentage will be calculated at the close of enrollment. Enrollment is estimated to end during Month 9 of Year 2.
Feasibility will be assessed by calculating enrollment rate (total number of patients enrolled / total number of patients approached). Feasible enrollment will be achieved by enrolling 80% or more of eligible caregivers.
Enrollment rate will be continually monitored throughout enrollment and final enrollment percentage will be calculated at the close of enrollment. Enrollment is estimated to end during Month 9 of Year 2.
Intervention Feasibility - Percentage of intervention sessions and follow-ups completed by enrolled participants.
Time Frame: Completion rates will be calculated during the study in real time as part of study monitoring. Final study completion rates will be reported after the final follow-up is complete. Follow-ups are estimated to be complete Month 11 of Year 2.
Feasibility will be assessed by calculating the percentage of MedMemos sessions attended and the number of follow-up visits completed. Feasibility will be achieved if 80% or more of MedMemos sessions are attended by participants and if 80% or more of follow-up visits are completed by participants.
Completion rates will be calculated during the study in real time as part of study monitoring. Final study completion rates will be reported after the final follow-up is complete. Follow-ups are estimated to be complete Month 11 of Year 2.
Intervention Feasibility - Percentage of the intervention protocol delivered by the interventionist.
Time Frame: Intervention fidelity will be monitored in real time to maintain adherence to the intervention protocol. Final intervention fidelity will be reported after the final MedMemos session is completed. Sessions are anticipated to end in Month 11 Year 2.
Feasibility of the intervention delivery will be assessed by calculating the intervention fidelity. Fidelity will be assessed by a member of the lab not involved in intervention delivery using a fidelity checklist developed by the study Principal Investigator. Feasibility of the intervention delivery will be achieved if fidelity checklist scores are 80% are greater (80% or more of the intervention delivered across the study)
Intervention fidelity will be monitored in real time to maintain adherence to the intervention protocol. Final intervention fidelity will be reported after the final MedMemos session is completed. Sessions are anticipated to end in Month 11 Year 2.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to immunosuppressant medication as assessed by electronic monitor
Time Frame: Daily adherence will be monitored for each patient after discharge through the 3-month follow-up.
To establish proof-of-concept adherence to immunosuppressants will be monitored for all patients. Proof-of-concept will be established if ≥75% children take ≥75% of their immunosuppressant medication doses at all follow-up time points as measured by electronic monitor.
Daily adherence will be monitored for each patient after discharge through the 3-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a rare treatment that treats even rarer diseases. Although identifiers will be removed from the final dataset, it will still include variables such as diagnosis treated by PAHCT, cell source for transplant (e.g., bone marrow, cord blood), date of transplant, and age at transplant that are frequently important to include in analyses. Given the rarity of this treatment, the investigators believe there remains the possibility of deductive disclosure of participants with uncommon characteristics (e.g., rare cancer diagnosis). To protect the rights and privacy of human subjects the investigators will not be sharing IPD, but instead will share de-identified aggregated qualitative data via the Cancer Data Service (CDS) database.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings