Recruiting

Digital Health Monitoring

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06647511

Conditions

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nokia-Withings BPM Connect Blood Pressure Monitor

Smartwatch Devices

Study Details

Brief summary:

The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are:

  • Can a digital monitoring system that checks for high blood pressure in these women be tested and refined, using clinical training and validation?
  • Can this digital monitoring system accurately track any related pregnancy health issues and be used to refer participants to care providers?
  • Can this system be used to accurately identify risks associated with the contraction of pregnancy-related conditions, such as preeclampsia and high blood pressure?

Participants will:

  • Complete baseline and follow-up in-person appointments;
  • Complete surveys at these appointment that track their health, stress levels, and comorbidities/risks associated with pregnancy;
  • Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements.

Conditions

Gestational Hypertension

Study ID

NCT06647511

Start date

Sep 12, 2024

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant
  • Refugee, asylum seeking, or asylee as designated by the U.S. Government
  • Greater than or equal to 18 years of age
  • Has a personal smartphone

Exclusion Criteria:

  • Unable to provide informed consent
  • Determined by the PI to be in an extremely vulnerable position and therefore not suited for research participation
  • Planned move from the New York City (NYC) area within the next 24 months

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant Refugees

Participants will complete validated questionnaires, regular blood pressure measurements, pain and trauma assessments, and clinical monitoring during this study.

Interventions

Nokia-Withings BPM Connect Blood Pressure Monitor

At-home blood pressure (BP) measurements will be weekly via a blood pressure cuff (e.g., Nokia-Withings BPM (Beats per Minute) Connect), with measurements being manually entered into the study specific smartphone app.

Smartwatch Devices

Passive continuous collection of digital data (e.g., daily heart rate trends, activity levels, sleep measurements) for exploratory outcomes will occur via Apple Watches and Fitbit Versa 3s, which are synced to a smartphone application.

Primary outcome measure

  • Digital Sensitivity for detecting gestational hypertension (HTN) [ Time Frame: 13 months [maximum duration of enrollment] ]

Central Contacts and Locations

Central contacts

Gunisha Kaur, MA, MD

(212) 746-2461gus2004@med.cornell.edu

Michele Steinkamp, RN

2127462953mls9004@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Gunisha Kaur, MA, MD

212-746-2461gus2004@med.cornell.edu

Michele Steinkamp, RN

212-746-2953mls9004@med.cornell.edu

Principal Investigator:

Gunisha Kaur, MA, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • refugee
  • pregnant
  • digital

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-04-22.