Recruiting

MHP 3.0

Sponsor:

Naima Health LLC

Code:

NCT04863521

Conditions

Telemedicine

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

MHP

Study Details

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.

Conditions

Telemedicine

Study ID

NCT04863521

Start date

Jun 20, 2022

Status verified date

Aug, 2022

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Mar 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: MHP Users

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.

Interventions

MHP

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.

Primary outcome measure

  • Change in number of patients that screen positive [ Time Frame: 8 months ]
  • Percentage of questionnaires completed [ Time Frame: 8 months ]
  • Usability Questionnaire [ Time Frame: 8 months ]
  • Acceptability Questionnaire [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Anabel F Castillo, PhD

4125873409anabel@naimahealth.com

Locations

Obstetrix Medical Center Houston

Recruiting

Houston, Texas, United States, 77477

Contacts

Olaide Ashimi, MD

412-587-3409olaide.ashimibalogun@pediatrix.com

More Information

Sponsor

Naima Health LLC

Last update posted

Aug 12, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Naima Health LLC on 2022-08-12.