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

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tjekkiet
      • Šumperk, Tjekkiet
        • Hospital Sumperk

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Andet: 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.
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant.
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Principal Engineering s.r.o.

Efterforskere

  • Ledende efterforsker: Karel Huml, MD, Hospital Sumperk

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. oktober 2025

Primær færdiggørelse (Anslået)

15. august 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Penelope_01_2025
  • 03/2025 (Registry Identifier: EK Český Těšín)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Præeklampsi (PE)

Kliniske forsøg med Control

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cote d'Ivoire

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner