The MedMemos Study: Promoting Adherence to Medications in Pediatric Bone Marrow Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MedMemos.
- Who it may be relevant to
- Registry conditions: Hematopoietic Cell Transplant. Basic parameters: 0 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MedMemos: An Intervention to Promote Medication Adherence in Pediatric Allogenic Hematopoietic Stem Cell Transplantation
Overview
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).
Interventions
- 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.
Primary outcome measures
- 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 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.]
- 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.]
- 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.]
Secondary outcome measures (1)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT07718204 · STUDY00004461