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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-12
SponsorNationwide Children's Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • MedMemos

    Behavioral

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: MedMemosExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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)
2

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.

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.
3

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.

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.
4

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)

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 outcomes

1

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.

Time frame
Daily adherence will be monitored for each patient after discharge through the 3-month follow-up.

Other outcomes

Sponsors and contacts

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