Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 4
- 主要终点
- Medication Possession Ratio (MPR)
研究概览
简要总结
The purpose of this research study is to learn about ways to help children and adults with sickle cell disease who are taking the medication, hydroxyurea.
详细描述
Sickle cell disease (SCD) is an inherited chronic multi-organ system disorder that affects approximately 100,000 individuals in the United States, mostly belonging to minority, under-served populations. SCD is associated with substantial morbidity, premature mortality, individual suffering, health care costs and loss of productivity. Hydroxyurea (HU) the only disease modifying therapy for SCD is efficacious in reducing complications such as pain crisis and acute chest syndrome and improving survival. It is however, vastly underutilized and poorly adhered to because of barriers at the health care system, provider, treatment, socioeconomic, and patient levels. The investigator's overarching hypothesis is that barriers to acceptance and adherence to HU are multi-factorial and that a structured set of interventions can lead to improved adherence to medication and patient centered outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be >2 years of age up to 65 years of age, inclusive
- •have a diagnosis of SCD, with either βS/βS, βS/βC, βS/βD, βS/β0, βS/βO-Arab, or βS/β+ genotype
- •prescribed Hydroxyurea for at least the 6 months prior to study entry
- •have daily access to a smart phone, tablet, personal computer or other device capable of producing and transmitting videos over the internet
- •be willing and able to record and transmit videos
排除标准
- •patient or caregiver refuses to take Hydroxyurea as treatment for SCD
- •diagnosis of significant psychiatric disorder of the subject that could seriously impede the ability to participate in the study
- •an assessment by the investigator that the subject will not comply with the study procedures outlined in the study protocol
- •patients receiving automatic home delivery of medications since medication possession ratio is reflective of the patient initiation the refill when they have exhausted the home supply of HU
研究组 & 干预措施
Adults - Mobile DOT
Subjects with SCD that are older than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
干预措施: Mobile DOT (Behavioral)
Adults - standard of care then Mobile DOT
Subjects with SCD that are older than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
干预措施: Mobile DOT (Behavioral)
Children - Mobile DOT
Subjects with SCD that are younger than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
干预措施: Mobile DOT (Behavioral)
Children - standard of care then Mobile DOT
Subjects with SCD that are younger than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
干预措施: Mobile DOT (Behavioral)
结局指标
主要结局
Medication Possession Ratio (MPR)
时间窗: 12 months
Proportion of days the patient is in possession of the medication in the study period
次要结局
- Change in mean cell volume (MCV)(Baseline, 24 months)
- Change in fetal hemoglobin (HbF) levels(Baseline, 24 months)
- Impact of adherence on clinical outcomes and healthcare utilization(Baseline, 24 months)
- Impact of adherence on patients' lives(Baseline, 24 months)
- Change in adherence with using Mobile-DOT(Baseline, 24 months)
- Change in Hemoglobin (Hb) levels(Baseline, 24 months)
- Acceptability of intervention and of Hydroxyurea(Baseline, 24 months)
研究者
Lakshmanan Krishnamurti
Professor
Emory University