Clinical Trials Logo

Clinical Trial 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 Healthcare System. Feedback from both patients and the care team will be assessed throughout this study. Patients will be assessed using a short acceptability and feasibility survey that will be administered by the Naima Health team by phone four times during the study term: week 14-18, week 24-28, week 34 and week 36-42.


Clinical Trial Description

For this study the investigators pilot MHP products in two clinical settings to determine their acceptability and feasibility in clinical practice. 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 Healthcare System for a 1-year period. Participants will receive MHP to use as part of their prenatal care, along with communication from the prescribing provider about how the app will be used and when the provider will have access to their information. Population and Sample Size: The investigators will recruit a sample of 75 patients from each clinical site in women's first trimester of pregnancy. In the case of Obstetrix Medical Group of Houston, the investigators will oversample for Spanish speakers (approximately 20% of our population). Women will be eligible for recruitment if they are at least 18 years old, are currently pregnant and under the care of a participating provider/clinic, own a smartphone, and are literate in English or Spanish. A site coordinator will identify eligible women to match our demographic requirements and introduce the study during an initial prenatal appointment, then consent women to the study. Data sources and collection (patients): A short acceptability and feasibility survey will be administered by the Naima Health team by phone three times during the study term. A final questionnaire will be conducted by phone between weeks 36-42 to review their psychosocial screening experience. Analytic Plan and Sample Size Considerations: The investigators will focus on feasibility (a priori defined as ≥ 67% completion of weekly questionnaires administered through the app) and acceptability (a priori defined as satisfaction scores of ≥ 4 on a 7-point Likert scale among ≥80% participants) as primary outcomes for this aim. Descriptive statistics will be used to characterize baseline demographic characteristics of the participants. The investigators will use point estimates (i.e. means and sample proportions) and 95% confidence intervals to characterize the sample with respect to baseline demographic characteristics. Debriefing interview transcripts will be coded for themes of acceptability, satisfaction, and barriers to app use. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04863521
Study type Interventional
Source Naima Health LLC
Contact Anabel F Castillo, PhD
Phone 4125873409
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 1, 2021
Completion date August 31, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03574480 - Smartphone Applications to Improve Lifestyles in Olders Over 65 Years N/A
Not yet recruiting NCT04070066 - Educational Strategy IN Exchange Transfusion N/A
Recruiting NCT04045054 - Home-based Transitional Telecare for Older Veterans N/A
Recruiting NCT04652674 - Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic N/A
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT02196428 - Medical Telemonitoring Plus Individual Teleconsultation in Elderly N/A
Completed NCT03025217 - Total Lifestyle Coaching Pilot Study (TLC) N/A
Completed NCT01820234 - Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event N/A
Recruiting NCT04392518 - Telerehabilitation in Proximal Muscle Weakness N/A
Not yet recruiting NCT04444323 - 3D Telemedicine During COVID-19: Cohort Study N/A
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Active, not recruiting NCT03474692 - Virta Health Registry
Completed NCT03007745 - Remote Sleep Apnea Management N/A
Completed NCT04789798 - The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey N/A
Active, not recruiting NCT01324687 - Study Of Telemedicine Consultation at Home For Older Adults N/A
Completed NCT00692497 - Electronic Referral and Booking of Outpatient Day Case Surgery Compared With Traditional Referral Routines. N/A
Completed NCT00527254 - Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient N/A
Completed NCT04312321 - Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial N/A
Not yet recruiting NCT04591873 - Using Telemedicine to Optimize Teamwork and Infection Control of Critical and Highly-infectious Patients in an Emergency Department
Completed NCT03646539 - RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood N/A