A Randomized Controlled Trial on the Use of Smartphone Message to Improve the Drug Compliance in Pregnant Women.
试验速览
- 阶段
- 不适用
- 入组人数
- 228
- 主要终点
- Compliance
研究概览
简要总结
As technology advances, smartphones are now widely available and can provide a convenient and effective means to improve drug compliance by sending an electronic reminder on a regular basis. In a meta-analysis of 16 RCTs in assessing of drug compliance in chronic diseases, text message significantly improves medication compliance (OR, 2.11; 95% CI, 1.52-2.93; P < 0.001). The drug compliance improves from 50% to 67.8%, or an absolute increase of 17.8%. Further evaluation is required as most of these RCTs relies on self-reported compliance. This data may be not applicable to pregnant women and trial of using this approach to improve drug compliance during pregnancy is lacking.
The investigators hypothesize that the use of smartphone message will improve the drug compliance in pregnant women requiring long term medications. The investigators propose a randomized controlled trial to evaluate the effect of smartphone message.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women age ≥ 18 years old
- •Able to receive electronic reminder through smartphohne
- •Gestational age less than 16 completed weeks as defined by pelvic ultrasound
- •Part 1: Need to take aspirin or progesterone for prevention of pre-eclampsia or preterm birth respectively
- •Part 2: Given multivitamin as health supplementation
排除标准
- •For Part 1:
- •History of adverse reaction to aspirin
- •History of adverse reaction to progesterone
- •History of breast or genital tract malignancy
- •History of suspected thromboembolic disease
- •Congenital uterine anomaly
- •Unwillingness or inability to comply with study procedures
- •Known paternal or maternal abnormal karyotype
结局指标
主要结局
Compliance
时间窗: through study completion, an average of 9months
number of tablet taken/ total number of tablets expected to take
次要结局
未报告次要终点