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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

25

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

May 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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