About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
MedMemos
BehavioralMedMemos 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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)
Secondary outcomes
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.
Sponsors and contacts
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