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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Intervention Acceptability [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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.]

Вторичные конечные точки (1)

• Adherence to immunosuppressant medication as assessed by electronic monitor [Срок оценки: Daily adherence will be monitored for each patient after discharge through the 3-month follow-up.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Nationwide Children's Hospital — Columbus

Идентификаторы

NCT: NCT07718204 · STUDY00004461

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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