A Randomized Controlled Trial on the Use of Smartphone Message to Improve the Drug Compliance in Pregnant Women.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- The University of Hong Kong
- Enrollment
- 228
- Primary Endpoint
- Compliance
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Smartphone
Receive daily whatsapp/ SMS message remind the drug intake.
Intervention: smartphone message (Device)
Control
receive instruction to take the medication at recruitment
Outcomes
Primary Outcomes
Compliance
Time Frame: through study completion, an average of 9months
number of tablet taken/ total number of tablets expected to take
Secondary Outcomes
No secondary outcomes reported