NCT04863521

Brief Summary

The purpose of this study is to assess the acceptability and feasibility of the use of MyHealthyPregnancy (MHP) 3.0 in clinical practice over a 1 year period of time. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the UPMC (University of Pittsburgh Medical Center) Healthcare System. Patient and care team feedback will be assessed throughout this study. Patients at Obstetrix Medical Group of Houston will be assessed using 4 short acceptability and feasibility surveys administered by the Naima Health team using a link for an online survey during the study term: at baseline, week 14-18, week 24-28, and week 34-36. A subset of participants at UPMC will also be asked to complete user surveys.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

April 16, 2021

Last Update Submit

August 9, 2022

Conditions

Telemedicine

Outcome Measures

Primary Outcomes (4)

  • Change in number of patients that screen positive

    Measured by the number of patients who screen positive for depression and/or intimate partner violence through the app compared to the number of patients who have screened positive for depression and/or intimate partner violence historically through routine prenatal care. Higher numbers mean better outcomes.

    8 months

  • Percentage of questionnaires completed

    Measured by calculating the percentage of questionnaires completed by each user from the total administered through the MHP app. Values would range from 0% to 100%. Higher numbers mean better outcomes.

    8 months

  • Usability Questionnaire

    This questionnaire will assess subjective opinions about the usability of MHP. This questionnaire includes 7 questions that will use a Likert scale anchored from 1/strongly disagree to 5/strongly agree. The minimum value is 7 and the maximum value of 35. Higher numbers mean better outcomes.

    8 months

  • Acceptability Questionnaire

    This questionnaire will assess subjective opinions about the acceptability of the content in MHP. This questionnaire includes 6 questions that will use a Likert scale anchored from 1/strongly disagree to 5/strongly agree. The minimum value is 6 and the maximum value of 30. Higher numbers mean better outcomes.

    8 months

Study Arms (1)

MHP Users

EXPERIMENTAL

A subset of the population within the clinical setting will be requested to participate in this pilot while the rest of the population will receive standard of care.

Other: MHP

Interventions

MHPOTHER

MyHealthyPregnancy app (MHP 3.0) is a mHealth app specifically focused on detection and referral for depression and IPV (Intimate Partner Violence) risk, in addition to its other pregnancy risk detection and support features.

MHP Users

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust be pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is at least 18 years of age
  • Currently pregnant and in gestational week 12 or less
  • Is under the care of a participating provider/clinic
  • Owns a smartphone
  • Spanish or English native speaker

You may not qualify if:

  • Under 18 years of age
  • Not pregnant at time of enrollment
  • Is pregnant but over 12 weeks of gestational age
  • Provider is not part of the study
  • Does not own a smartphone
  • Native language is not Spanish or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrix Medical Center Houston

Houston, Texas, 77477, United States

RECRUITING

Central Study Contacts

Anabel F Castillo, PhD

CONTACT

4125873409anabel@naimahealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Users recruited at Obstetrix Medical Group of Houston will participate in a pilot study that includes facilitating access to the app and will be followed throughout their pregnancy using online surveys. Users at the UPMC Healthcare System are already using the app as part of their routine care and will be asked to complete an online survey about their user experience.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 28, 2021

Study Start

June 20, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

August 12, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)