Hematopoietic Cell Transplant
Conditions
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
Brief 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 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
BEHAVIORALMedMemos
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.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All enrolled participants will receive the MedMemos Intervention.
Eligibility
Sex/Gender
ALL
Age
0 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability | 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 | 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. | 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. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to immunosuppressant medication as assessed by electronic monitor | Daily adherence will be monitored for each patient after discharge through the 3-month follow-up. | 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. |
Countries
United States
Contacts
CONTACTAhna LH Pai, PhD
CONTACTSarah N Drake, MS
Outcome results
None listed