- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04295265
Smartphone Message to Improve the Drug Compliance in Pregnant Women.
A Randomized Controlled Trial on the Use of Smartphone Message to Improve the Drug Compliance in Pregnant Women.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Smartphone
Receive daily whatsapp/ SMS message remind the drug intake.
|
Receive daily whatsapp/ SMS message to remind the drug intake
|
Ingen indgriben: Control
receive instruction to take the medication at recruitment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Compliance
Tidsramme: through study completion, an average of 9months
|
number of tablet taken/ total number of tablets expected to take
|
through study completion, an average of 9months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UW 19-552
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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