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Implementering af digitalt moderskabsstøtteværktøj

2. oktober 2026 opdateret af: Tamar Krishnamurti, University of Pittsburgh

Implementering af digitalt moderstøtteværktøj: Forskning til at informere en statsdækkende implementeringsstrategi for en postpartum-app

The goal of this trial is to learn if a smartphone app designed to provide postpartum support is acceptable to new mothers in Pennsylvania. The main questions it aims to answer are:

  • How easy is the app is to use?
  • Does the app meet the needs of new parents?
  • Is using the app associated with better understanding of critical postpartum symptoms?
  • Is using the app associated with endorsement of positive parenting statements?

Participants will:

  • Use a postpartum support app on their smartphones for 8 weeks
  • Answer survey questions about their experience

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The goal of this clinical trial is to evaluate the feasibility and acceptability of a smartphone app designed to provide postpartum education, screening and tracking, and positive parenting support for newly postpartum English-language speakers in Pennsylvania. This trial will also examine the preliminary effectiveness of the smartphone app for identifying symptoms and supporting positive parenting beliefs by measuring knowledge and attitude changes from pre-app use to post-app use.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC Magee-Womens Hospital

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

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Recently delivered one or two live births at hospital recruitment site
  • 18-45 years of age
  • Can participate in English
  • Has smartphone access for at least two months (study duration)

Exclusion Criteria:

  • Did NOT recently deliver one or two live births at hospital recruitment site
  • <18 or >45 years of age
  • Cannot participate in English
  • Does not have smartphone for at least two months (study duration)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Postpartum support app

All study participants will be given access to a postpartum support app. They will be asked to use this app for 8 weeks. Periodic surveys will be administered at 10 days, 4 weeks, and 8 weeks post enrollment. Baseline measurements will be collected at enrollment.

The smartphone app is designed to provide postpartum education, screening and tracking, and positive parenting support for newly postpartum English-language speakers in Pennsylvania.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability of App
Tidsramme: Day 10, Week 4, and Week 8 of study participation

20 questions tailored from the Unified Theory of Acceptance of Use of Technology (UTAUT) asked at 3 study timepoints: 10 days, 4 weeks, and 8 weeks. 11 of the 20 questions are repeated across timepoints that assess the smartphone app (e.g., "The amount of information in [the app] is what I need" or "Overall, I like [the app]"). The remaining 9 are specific to distinct features of the app that are made available to the user at specific timepoints (e.g., "I like the way the healing check-in looks and feels"; "I like the way the [2-month] baby milestones look and feel"). Answers are measured on a 5-point Likert scale, ranging from (1)strongly disagree to (5) strongly agree (5), unless reverse-coded. Means and standard deviations will be calculated for each item, with higher responses indicating higher levels of acceptability.

Day 10, Week 4, and Week 8 of study participation
Feasibility of App Use
Tidsramme: From enrollment (baseline) to the end of study participation at 8 weeks.

Feasibility will be measured using rate of engagement. Engagement will be evaluated by the number of study weeks that users uniquely access the smartphone app.

From enrollment (baseline) to the end of study participation at 8 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knowledge - postpartum symptoms
Tidsramme: Enrollment (baseline), day 10, week 4, and week 8 of study participation

From a list of 14 postpartum symptoms, participants will be asked to classify the symptom with the appropriate response: monitor at home, call your provider, or call 911/seek emergency care. Baseline knowledge will be measured at enrollment based on the number correct out of 14, with follow-up measurements taken at 10 days, 4 weeks, and 8 weeks.

Enrollment (baseline), day 10, week 4, and week 8 of study participation
Attitudes - positive parenting
Tidsramme: Enrollment (baseline), day 10, week 4, and week 8 of study participation

From a list of 10 statements focused on parenting practices, participants will rate the statements from strongly disagree (1) to strongly agree (5). Example statements include, "Skin-to-skin contact improves baby health and development," "Babies need strict routines" (reverse coded), and "Infants should be fed when they show hunger cues." These responses are summed, with higher scores indicating stronger endorsement of positive parenting. These measurements are taken as a baseline measurement at enrollment, and then again at 10 days, 4 weeks, and 8 weeks.

Enrollment (baseline), day 10, week 4, and week 8 of study participation

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health services utilization
Tidsramme: Day 10, week 4, and week 8 of study participation

Well-visit (maternal) and check-up (infants) attendance are surveyed on day 10, week 4, and week 8 (e.g., "Has your baby (or twins) had their first well visit with their pediatrician yet?" or "Have you attended a postpartum check-up?"). Non-routine healthcare utilization is surveyed at week 4 and week 8 (e.g., "In the last 4 weeks, did your baby (or twins) have a visit at an emergency department?"or "In the last 8 weeks, did you call, message or schedule a visit with your Obstetrician or Primary Care Provider for a reason other than a postpartum check-up?"). Distributions for each response will be used for analysis.

Day 10, week 4, and week 8 of study participation

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Tamar Krishnamurti, PhD, University of Pittsburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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)

1. december 2025

Primær færdiggørelse (Faktiske)

29. maj 2026

Studieafslutning (Faktiske)

29. maj 2026

Datoer for studieregistrering

Først indsendt

3. december 2025

Først indsendt, der opfyldte QC-kriterier

15. december 2025

Først opslået (Faktiske)

19. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STUDY24110002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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