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Cost-Effectiveness of an mHealth Application in Pregnancy Care (Penelope)

1. června 2026 aktualizováno: Principal Engineering s.r.o.

Cost-Effectiveness of an mHealth Application in Pregnancy Care: A Randomized Multi-Center Study Comparing Penelope Users and Non-Users

Participants will be randomly assigned to either the intervention arm (mHealth application users) or the control arm, in which participants will record their data on paper or in Excel according to standard practice or the recommendation of their study physician.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

Participants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyze a range of health-related data, including self-reported symptoms, blood pressure measurements, and proteinuria test results. The application processes these data and evaluates the degree of deviation of measured values from predefined normal ranges. Each parameter is assessed on a scale of 1 to 3, with threshold values indicating increased risk established in collaboration with the study physician and in accordance with standards of care.

The study physician is informed of deviations from normal values through color-coded indicators displayed within the application (without automated notifications), based on which further clinical management may be determined.

Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data according to instructions provided by their study physician and in accordance with standard care protocols and routine clinical practice. These instructions will be provided at the same time points as those used in the intervention arm, ensuring comparable follow-up throughout the study period. Participants in the control arm will be instructed to adhere consistently to the data collection and self-monitoring procedures until delivery.

Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No aspect of standard care will be withheld from any participant. All participants will continue to receive routine prenatal care and attend scheduled prenatal visits in accordance with established clinical guidelines.

Typ studie

Intervenční

Zápis (Odhadovaný)

250

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Česko
      • Šumperk, Česko
        • Hospital Sumperk

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

• Age between 18 and 45 years. Each participant will be enrolled in the study no earlier than the 20th week of pregnancy.

Presence of at least one primary risk factor:

  • Pre-gestational hypertension.
  • Gestational hypertension.
  • Positive screening for preeclampsia.

The presence of additional secondary risk factors (e.g., controlled type 1 or type 2 diabetes mellitus, obesity with BMI ≥ 30) may be recorded but is not sufficient on its own for inclusion in the study without meeting at least one primary criterion.

Exclusion Criteria:

  • Uncontrolled diabetes and/or diabetes during the last 3 months prior to enrolment in this study.
  • Presence of a gynaecological disease that increases the risk of pregnancy complications, except for those conditions specifically listed in the inclusion criteria (e.g., chronic hypertension, gestational hypertension, pre-gestational hypertension, diabetes mellitus, obesity, or morbid obesity).
  • Participant with active malignant disease.
  • Participant with alcohol or drug abuse during the recruitment and during the trial course.
  • Participant enrolled in another clinical trial during the last 3 months prior to enrolling in this study.
  • Participants who, in the opinion of the study physician, may interfere with optimal participation in the study or may pose a risk to the participant.
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the participant may have poor compliance with the study protocol.
  • Participants with severe or uncontrolled depression, which in the opinion of the study physician could influence participant's participation in the study; participants with stable depression and/or on a stable dose of an anti-depressant for at least three months may be included.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Participants in the intervention arm will use the mHealth application daily from gestational week 20
Participants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyse a range of health-related data, including self-reported symptoms, blood pressure measurements and proteinuria test results. The application processes data and evaluates the degree of deviation of measured values from normal (note: each value can be on a scale of 1-3, with threshold values for classification as risky defined in collaboration with study physician in accordance with standards of care).
Jiný: Control

Control arm will monitor and record their health data following instructions provided by their study

Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data following instructions provided by their study physician in accordance with standard care protocols and the routine clinical practices of their respective healthcare providers. These instructions will be provided at the same time points as in the intervention arm, ensuring that both arms receive comparable follow-up throughout the study period. Control arm participants will be instructed to consistently adhere to the data collection and self-monitoring procedures until delivery. Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No standard care will be withheld by any participant; all participants will continue to attend routine prenatal visits in accordance with established clinical guidelines.
Jiný: Control arm will monitor and record their health data following instructions provided by their study

Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data following instructions provided by their study physician in accordance with standard care protocols and the routine clinical practices of their respective healthcare providers. These instructions will be provided at the same time points as in the intervention arm, ensuring that both arms receive comparable follow-up throughout the study period. Control arm participants will be instructed to consistently adhere to the data collection and self-monitoring procedures until delivery.

Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No standard care will be withheld by any participant; all participants will continue to attend routine prenatal visits in accordance with established clinical guidelines.
Jiný: mHealth application Penelope

Participants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyse a range of health-related data, including self-reported symptoms, blood pressure measurements and proteinuria test results. The application processes data and evaluates the degree of deviation of measured values from normal (note: each value can be on a scale of 1-3, with threshold values for classification as risky defined in collaboration with study physician in accordance with standards of care).

The study physician is alerted to the degree of deviation from normal values in the application by means of color identifiers (not notifications), on the basis of which he or she can decide on further steps.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant.
Časové okno: From gestational week 20 until delivery (up to approximately 22 weeks).

Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant.

• Includes:

  • Direct medical costs (e.g. clinic visits, procedures)
  • Digital platform costs (development, maintenance, IT support, amortized per user)
  • Indirect non-medical costs (travel, productivity loss, childcare)
From gestational week 20 until delivery (up to approximately 22 weeks).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Principal Engineering s.r.o.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Karel Huml, MD, Hospital Sumperk

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

6. října 2025

Primární dokončení (Odhadovaný)

15. srpna 2026

Dokončení studie (Odhadovaný)

30. září 2026

Termíny zápisu do studia

První předloženo

20. května 2026

První předloženo, které splnilo kritéria kontroly kvality

1. června 2026

První zveřejněno (Aktuální)

2. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Penelope_01_2025
  • 03/2025 (Identifikátor registru: EK Český Těšín)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Control

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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