Smartphone Message to Improve the Drug Compliance in Pregnant Women.

NCT ID: NCT04295265

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Smartphone

Receive daily whatsapp/ SMS message remind the drug intake.

Group Type EXPERIMENTAL

smartphone message

Intervention Type DEVICE

Receive daily whatsapp/ SMS message to remind the drug intake

Control

receive instruction to take the medication at recruitment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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smartphone message

Receive daily whatsapp/ SMS message to remind the drug intake

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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UW 19-552

Identifier Type: -

Identifier Source: org_study_id

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