- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07295015
Digital Maternal Support Tool Implementation
December 15, 2025 updated by: Tamar Krishnamurti, University of Pittsburgh
Digital Maternal Support Tool Implementation: Research to Inform a Statewide Postpartum App Implementation Strategy
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
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tamar Krishnamurti, PhD
- Phone Number: 412-383-5556
- Email: tamark@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- UPMC Magee-Womens Hospital
-
Contact:
- Anne-Marie Rick, MD, MPH, PhD
- Phone Number: 610-349-5571
- Email: annemarie.rick@chp.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of App
Time Frame: 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
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge - postpartum symptoms
Time Frame: 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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health services utilization
Time Frame: 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.
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Day 10, week 4, and week 8 of study participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tamar Krishnamurti, PhD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 3, 2025
First Submitted That Met QC Criteria
December 15, 2025
First Posted (Actual)
December 19, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY24110002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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