Hematopoietic Cell TransplantMedMemosNCT07718204
The MedMemos Study: Promoting Adherence to Medications in Pediatric Bone Marrow Transplant Patients
A study testing MedMemos in people with Hematopoietic Cell Transplant, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Hematopoietic Cell Transplant
- What is being tested?
- MedMemos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Ahna LH Pai, PhD, (614) 938-1601, Ahna.Pai@nationwidechildrens.org
Sarah N Drake, MS, (614) 259-7462, sarah.drake2@nationwidechildrens.org
About this study
Official title: 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.
Read the 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).
- Conditions
- Hematopoietic Cell Transplant
- Being tested
- MedMemos
- Keywords
- Hematopoietic Cell Transplantation, Bone Marrow Transplant, Pediatric, Cancer, Bone Marrow Failure, Adherence, Medication Adherence, Non-Adherence, Adherence Promotion Intervention, Immunosuppressant, Transition to Outpatient, Managing Medication Regimens, Child, Caregiver, Parent, GVHD, Infection
- Medical subject headings
- Neoplasms, Bone Marrow Failure Disorders, Medication Adherence, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedMemosBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MedMemos | Experimental | This arm will provide participants with the MedMemos Intervention Receives: Behavioral: MedMemos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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)
Measured: 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 outcomes (1)
Adherence to immunosuppressant medication as assessed by electronic monitor
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.
Measured: Daily adherence will be monitored for each patient after discharge through the 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Cell TransplantStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the MedMemos Intervention.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahna Pai, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718204
- Sponsor's protocol ID
- STUDY00004461
- Acronym
- MedMemos
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MedMemos: An Intervention to Promote Medication Adherence in Pediatric Allogenic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07718204
- Acronym / sponsor ID
- MedMemos / STUDY00004461
- Conditions
- Hematopoietic Cell Transplant
- Keywords
- Hematopoietic Cell Transplantation, Bone Marrow Transplant, Pediatric, Cancer, Bone Marrow Failure, Adherence, Medication Adherence, Non-Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the MedMemos Intervention.
| Arm | Type | Receives |
|---|---|---|
| MedMemos | Experimental | Behavioral: MedMemosThis arm will provide participants with the MedMemos Intervention |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MedMemosMedMemos 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. | Behavioural | MedMemos |
Primary outcome
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.
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.
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.
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)
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedMemos in people with Hematopoietic Cell Transplant, run by Nationwide Children's Hospital 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahna LH Pai, PhD ((614) 938-1601, Ahna.Pai@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 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 21 Jul 2026.