Effect of Mobile-Directly Observed Therapy (DOT) on Adherence to Hydroxyurea Treatment in Adult HbSS Patients at Muhimbili National Hospital (MNH) in Tanzania: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- The proportion of participants achieving ≥80% HU adherence as assessed through medication possession ratio.
研究概览
简要总结
To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.
详细描述
Background: Hydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with Sickle Cell Anemia (SCA) but poor adherence is a barrier to improving outcomes in patients with SCA. Directly Observed Therapy (DOT) has been shown to improve adherence in various chronic diseases but there is limited data in adults with sickle cell anaemia (SCA).
Methods and design: To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.The mDOT-HuA study is single centre, prospective, randomized, open label clinical trial. 100 participants with SCA with hemoglobin SS genotype, aged ≥18 years, living in urban Dar es Salaam and able and willing to participate in the study. Participants will be divided into two treatment arms; 50 in standard monitoring (SM) arm: will receive fixed dose HU therapy with standard monitoring. 50 in treatment mDOT arm: will receive fixed dose HU therapy with standard monitoring and a mobile direct observed web based medication adherence monitoring system. The primary outcome is adherence to HU as defined as medication possession ratio of ≥80 at end of 3 months of HU treatment and mDOT monitoring. Secondary outcomes will be efficacy to HU treatment as measured through the the mean change in fetal hemoglobin (between baseline and end of 3 months) and safety, measured as the proportion of participants experiencing serious adverse events related to HU at week 2, 6, 10 and at the end of 3 months.
REDCap, an open source software application will be used to collect data using clinical research forms.
Conclusion: This project has the potential for the development of novel strategies for improving HU adherence in SCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years and living in urban Dar es Salaam
- •Male or female (post-menopausal, sterile, or using an acceptable method of contraception)
- •Negative urine pregnancy test at Screening and a negative urine pregnancy test (dipstick) prior to randomization and dosing
- •Hemoglobin SS genotype
- •Absolute neutrophil count >1,500/uL
- •Platelet count >95,000/uL
- •Serum creatinine< 100 µmol/L (1.2 mg/dL)
- •Alanine transaminase (ALT) less than two times the upper limit of normal
- •Being able and willing to record and submit videos electronically
排除标准
- •Chronic transfusion program as defined by participating in a scheduled (pre-planned) series of transfusions for prophylactic purposes or has a hemoglobin A level that is >20% of the total hemoglobin
- •Hemoglobin <4.0 g/dL
- •HIV positive
- •Female planning to become pregnant during the study period
- •Serious mental (including psychosis) or physical illness, which, in the opinion of the Investigators would compromise participation in the study (e.g. impaired mental capacity, alcoholism
- •Any condition which the Investigators judge to preclude safe participation in the study or to confound the evaluation of the study outcome.
研究组 & 干预措施
Standard monitoring (SM) arm
Participants will receive fixed dose hydroxyurea therapy (15 mg/Kg/day) with standard monitoring. Standard monitoring is defined as a follow-up visit two weeks after initiation of therapy and monthly follow-ups thereafter
干预措施: Hydroxyurea (Drug)
mDOT arm
Participants will receive fixed dose hydroxyurea therapy (15 mg/Kg/day) and Mobile Directly Observed Therapy (mDOT) consisting of a web based medication adherence monitoring system that includes direct video confirmation of adherence using the patient's personal cellular telephone. Participants will receive alerts on their cell phone at pre-arranged times to remind them to take their medications. Participants will be followed-up at two weeks after initiation of therapy and monthly thereafter.
干预措施: Hydroxyurea (Drug)
mDOT arm
Participants will receive fixed dose hydroxyurea therapy (15 mg/Kg/day) and Mobile Directly Observed Therapy (mDOT) consisting of a web based medication adherence monitoring system that includes direct video confirmation of adherence using the patient's personal cellular telephone. Participants will receive alerts on their cell phone at pre-arranged times to remind them to take their medications. Participants will be followed-up at two weeks after initiation of therapy and monthly thereafter.
干预措施: Mobile Directly Observed Therapy (Device)
结局指标
主要结局
The proportion of participants achieving ≥80% HU adherence as assessed through medication possession ratio.
时间窗: At the end of 3 months of Hydroxyurea treatment and monitoring.
The proportion of participants achieving ≥80% HU adherence will compared between the two arms.
次要结局
- Efficacy of Hydroxyurea treatment as measured through the mean change in fetal hemoglobin (%),(At the end of 3 months of Hydroxyurea treatment and monitoring.)
- The proportion of participants experiencing serious adverse events (SAE) related to hydroxyurea(at week 2, 6 ,10 and at the end of 3 months of Hydroxyurea treatment and monitoring.)
研究者
Ábel Makubi
Senior Lecturer
Muhimbili University of Health and Allied Sciences