MedMemos: An Intervention to Promote Medication Adherence in Pediatric Allogenic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Intervention Acceptability
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Intervention Acceptability
时间窗: 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
时间窗: 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.
时间窗: 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.
时间窗: 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)
次要结局
- 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.)
研究者
Ahna Pai
Professor
Nationwide Children's Hospital