Smartphone Message to Improve the Drug Compliance in Pregnant Women.

NCT04295265 | Unknown

• 1 other identifier: UW 19-552
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Compliance

  number of tablet taken/ total number of tablets expected to take

  through study completion, an average of 9months

Study Arms (2)

Smartphone

EXPERIMENTAL

Receive daily whatsapp/ SMS message remind the drug intake.

Device: smartphone message

Control

NO INTERVENTION

receive instruction to take the medication at recruitment

Interventions

smartphone message DEVICE

Receive daily whatsapp/ SMS message to remind the drug intake

Smartphone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: March 4, 2020
• Study Start: March 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2024
• Last Updated: March 4, 2020

Record last verified: 2020-03