- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07295015
Digitalt implementeringsverktyg för modersstöd
Implementering av digitalt stöd för mödrar: Forskning för att informera en statlig implementeringsstrategi för 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- UPMC Magee-Womens Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acceptability of App
Tidsram: 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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Knowledge - postpartum symptoms
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Health services utilization
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Tamar Krishnamurti, PhD, University of Pittsburgh
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- STUDY24110002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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