[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07718204":3,"trial-entities:NCT07718204":119,"trial-summary:NCT07718204":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":38,"primary_purpose":39,"phases":40,"enrollment_info":42,"interventions":45,"primary_outcomes":51,"secondary_outcomes":68,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":90,"locations":92,"central_contacts":113,"overall_officials":116,"references":117,"see_also_links":118},"NCT07718204","STUDY00004461","The MedMemos Study: Promoting Adherence to Medications in Pediatric Bone Marrow Transplant Patients","MedMemos: An Intervention to Promote Medication Adherence in Pediatric Allogenic Hematopoietic Stem Cell Transplantation","RECRUITING","2028-12-31","2026-07","2026-07-21","2026-05-01","Nationwide Children's Hospital","OTHER",false,"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:\n\n* Is the MedMemos intervention acceptable to patients and families?\n* Is the MedMemos intervention feasible for patients, families, and healthcare providers?\n* Does MedMemos help patients and families take their medications better?\n\nParticipants will be asked to complete surveys, attend 4 intervention sessions, and use an electronic box or pill bottle to store their medications in.","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).",[19],"Hematopoietic Cell Transplant",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"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","INTERVENTIONAL","SUPPORTIVE_CARE",[41],"NA",{"count":43,"type":44},25,"ESTIMATED",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50},"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.",[48],[52,56,60,64],{"measure":53,"description":54,"timeFrame":55},"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.","At the end of session 4 (An average of 14 days following the patient's hospital discharge, up to 28 days following discharge)",{"measure":57,"description":58,"timeFrame":59},"Intervention Feasibility - Percentage of patients who enroll out of those approached","Feasibility will be assessed by calculating enrollment rate (total number of patients enrolled \u002F 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.",{"measure":61,"description":62,"timeFrame":63},"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.","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.",{"measure":65,"description":66,"timeFrame":67},"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)","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.",[69],{"measure":70,"description":71,"timeFrame":72},"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.","Daily adherence will be monitored for each patient after discharge through the 3-month follow-up.","ALL","0 Years","12 Years",{"inclusion":77,"exclusion":83,"raw_text":89},[78,79,80,81,82],"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",[84,85,86,87,88],"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","Inclusion Criteria:\n\n* Child had a Pediatric Allogeneic Hematopoietic Cell Transplant (PAHCT)\n* Child is 0-12 years of age\n* At the time of recruitment child is still in the hospital for PAHCT\n* Child's primary caregiver is responsible for administering medical care and is willing to give consent to participate\n* Child is prescribed an oral medication regimen at discharge\n\nExclusion Criteria:\n\n* Caregiver does not speak English, Spanish, or Arabic\n* Caregiver is not available to provide written permission for the child's participation\n* EMR or medical team report of the caregiver's cognitive status precludes completion of questionnaires\n* The child's medical status or condition precludes completion of the study questionnaires as determined by the physician or caregiver\n* Caregiver is unwilling to store medication in an electronic monitor",[91],"CHILD",[93],{"facility":13,"status":8,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":110},"Columbus","Ohio","43205","United States",[99,104,108],{"name":100,"role":101,"phone":102,"email":103},"Ahna LH Pai, PhD","CONTACT","(614) 938-1601","Ahna.Pai@nationwidechildrens.org",{"name":105,"role":101,"phone":106,"email":107},"Sarah N Drake, MS","(614) 259-7462","sarah.drake2@nationwidechildrens.org",{"name":100,"role":109},"PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},39.96118,-82.99879,[114,115],{"name":100,"role":101,"phone":102,"email":103},{"name":105,"role":101,"phone":106,"email":107},[],[],[],{"nct_id":4,"conditions":120,"biomarkers":121},[21],[],{"nct_id":4,"found":123,"summary":124,"prompt_version":134},true,{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study, meaning participants will receive the MedMemos program. It aims to enroll 25 participants.","completed","The MedMemos Study: Promoting Medication Adherence in Pediatric Bone Marrow Transplant Patients","This study, called MedMemos, is testing a new way to help parents and children take their medications correctly after a bone marrow transplant (hematopoietic cell transplant). The MedMemos program includes four sessions with educational videos and a \"Medication Management Kit\" to help families overcome challenges with taking medicines. We want to see if families find MedMemos helpful and easy to use, and if it helps children take their medications better. Children aged 0 to 12 years who have had a bone marrow transplant and are still in the hospital can join if their caregiver is willing to participate. We plan to enroll 25 participants.","Intervention acceptability will be measured around 14-28 days after hospital discharge. Completion rates will be monitored throughout the study, with final rates reported after follow-ups are complete, estimated around Month 11 of Year 2.",104,"Participants will complete surveys, attend 4 intervention sessions, and use an electronic box or pill bottle to store their medications.","Not stated in the trial record.",[48],"v2"]