MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication.
详细描述
PRIMARY OBJECTIVE:
I. To compare the mean change in 6-mercaptopurine chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2) between pediatric patients with ALL randomized to MedSupport intervention versus usual care
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 12 months (T3) between pediatric patients with ALL randomized to MedSupport intervention versus usual care
SECONDARY OBJECTIVES;
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2) within pediatric patients with ALL randomized to MedSupport intervention versus usual care
- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 12 months (T3) within pediatric patients with ALL randomized to MedSupport intervention versus usual care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent of a child diagnosed with acute lymphoblastic leukemia (ALL)
- •Child patient age 365 days to < 19 years at time of study entry.
- •Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube.
- •Verbal fluency in English, or Spanish
- •Parent has a smartphone or computer access with an Internet connection.
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
排除标准
- •Parent is unwilling or unable to follow protocol requirements.
研究组 & 干预措施
Arm A (MedSupport)
Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm A (MedSupport)
Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm A (MedSupport)
Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Interview (Other)
Arm A (MedSupport)
Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Medical Device Usage and Evaluation (Other)
Arm A (MedSupport)
Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Survey Administration (Other)
Arm B (usual care)
Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Best Practice (Other)
Arm B (usual care)
Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm B (usual care)
Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm B (usual care)
Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Interview (Other)
Arm B (usual care)
Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Medical Device Usage and Evaluation (Other)
Arm B (usual care)
Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Medication adherence
时间窗: Up to 1 year
Will be summarized by timepoint (baseline, 6-months, and 1-year) and condition using descriptive statistics and graphical summaries. The primary analysis will model log adherence as a function of condition, timepoint, their two-way interaction, and random family (accounting for the longitudinal measures within a family unit) and site (accounting for between cancer center variability) effects using a linear mixed model (LMM). Bonferroni adjusted tests about the appropriate contrasts of model estimates will be used to compare: 1) the mean change in adherence within each condition, 2) retention of effect at 12-months within each condition, and 3) the mean change in adherence between conditions.
次要结局
未报告次要终点